Medical devices: Class I devices; premarket notification requirements; exemption designations,

[Federal Register: November 12, 1998 (Volume 63, Number 218)]

[Proposed Rules]

[Page 63222-63253]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr12no98-24]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892

[Docket No. 98N-0009]

Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is proposing to designate as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA.

DATES: Written comments by January 26, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for Device and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.

SUPPLEMENTARY INFORMATION:

1. Statutory Background

   Under section 513 of the act (21 U.S.C. 360c), FDA must classify devices

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   into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the 1976 amendments (Pub. L. 94-295), as amended by the SMDA (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the act are sufficient to ensure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.

   Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the implementing regulations, part 807 (21 CFR part 807), require persons who intend to market a new device to submit a premarket notification report (510(k)) containing information that allows FDA to determine whether the new device is substantially equivalent within the meaning of section 513(i) of the act to a legally marketed device that does not require premarket approval. Unless exempted from premarket notification requirements, persons may not market a new device under section 510(k) of the act, unless they receive a substantial equivalence order from FDA or an order reclassifying the device into class I or class II, under section 513(f) of the act.

   On November 21, 1997, the President signed FDAMA into law (Pub. L. 105-115). Section 206 of FDAMA, in part, added a new section 510(l) to the act. Under section 206 of the FDAMA, new section 510(l) of the act became effective on February 19, 1998. New section 510(l) of the act provides that a class I device is exempt from the premarket notification requirements under section 510(k) of the act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. This document refers to these devices that FDA believes meet these criteria as ``reserved.'' FDA has evaluated all class I devices to determine which device types should be subject to premarket notification requirements.

   In developing the list of reserved devices, the agency considered its experience in reviewing premarket notifications for these device types, focusing on the risk inherent with the device and/or the disease being treated or diagnosed. FDA believes that the devices listed as reserved are intended for a use that is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury.

   In the Federal Register of February 2, 1998 (63 FR 5387), FDA published a list of devices it considered reserved and that require premarket notification and a list of devices it believed met the exemption criteria in FDAMA. FDA invited comments on the February 2, 1998, notice. Responses to these comments are addressed in this document.

   FDA is now proceeding to designate which devices require premarket notification, and which are exempt, subject to limitations, under notice and comment rulemaking proceedings under new section 510(l). The devices FDA is proposing to designate as requiring premarket notification include five devices that are currently exempt from premarket notification because FDA believes they meet the reserved criteria: Quinine test system Sec. 862.3750 (21 CFR 862.3750), Sulfonamide test system Sec. 862.3850 (21 CFR 862.3850), Cardiopulmonary bypass accessory equipment Sec. 870.4200 (21 CFR 870.4200), Ophthalmic eye shield Sec. 886.4750 (21 CFR 886.4750) (when made of other than plastic or aluminum), and Electrode cable Sec. 890.1175 (21 CFR 890.1175). FDA also is proposing to modify the limitations language for all class I devices that are currently exempt.

2. Limitations on Exemptions

   FDA believes that the generic types of class I devices listed herein, in addition to a vast majority of class I devices previously exempted, should be exempt from the premarket notification requirements under section 510(l) of the act. FDA further believes, however, that these generic device categories should be exempt only to the extent that they have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices (IVD's), for which a misdiagnosis as a result of using the device, would not be associated with high morbidity or mortality. FDA believes that certain changes to devices within a generic device type that is generally exempt may make the device intended for a use that is of substantial importance in preventing impairment of human health or may make the device present a potential unreasonable risk of illness or injury. Accordingly, devices changed in this manner would fall within the reserved criteria under section 510(l) of the act and would require premarket notification.

   FDA believes that devices that have different intended uses than legally marketed devices in that generic device type present a potential unreasonable risk of illness or injury because their safety and effectiveness characteristics are unknown. Moreover, FDA believes that IVD's that are intended for a use for which a misdiagnosis, as a result of using the device, could result in high morbidity or mortality, either are intended for a use that is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury.

   Accordingly, because FDA believes that devices incorporating the characteristics described previously fit within the reserved criteria under section 510(l) of the act, FDA considers any class I device to be subject to premarket notification requirements if the device: (a) Has an intended use that is different from the intended use of a legally marketed device in that generic type of device (e.g., the device is intended for a different medical purpose, or the device is intended for lay use instead of use by health care professionals); or (b) operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type of device (e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an IVD detects or identifies infectious agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization or amplification technology rather than culture or immunoassay technology); or (c) is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical

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   devices; (2) for use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) for measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) to assess the risk of cardiovascular diseases; (5) for use in diabetes management; (6) to identify or infer the identity of a microorganism directly from clinical material; (7) for detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) for noninvasive testing as defined in Sec. 812.3(k) (21 CFR 812.3(k); and (9) for near patient testing (point of care).

   FDA is proposing to revise Secs. 862.9, 864.9, and 866.9 (21 CFR 862.9, 864.9, and 866.9) to incorporate the revised limitations on exemptions for IVD's as set forth previously. FDA believes that these limitations, for the reasons described previously, are appropriate for IVD's.

   FDA is also proposing to amend all current limitations on exemptions sections (21 CFR 862.9, 864.9, 866.9, 868.9, 870.9, 872.9, 874.9, 876.9, 878.9, 880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 892.9) in two ways. First the proposed limitations language clarifies that these limitations apply to class II, as well as class I devices. On January 21, 1998 (63 FR 3142), FDA published a list of exempted class II devices, subject to certain limitations. Under section 510(m)(1), as added by FDAMA, FDA was provided the authority to exempt these class II devices upon issuance of a notice. FDA intends to codify these exemptions, including the limitations described in the January 21, 1998, Federal Register notice, by issuance of a final rule in the near future.

   The limitations language that is proposed in this document for class I devices is identical to those limitations for class II devices that became effective on January 21, 1998. Accordingly, the proposed limitations sections state that the scope of these limitations apply to class II, as well as class I devices.

   Second, FDA is proposing to amend the limitations language to state that premarket notifications must be submitted for class I exempt devices if the intended use is different than the ``legally marketed devices in that generic type.'' Currently, the limitations in Sec. ______.9 of each classification regulation part (e.g., Secs. 862.9, 864.9, etc.) states that manufacturers must submit premarket notifications for class I exempt devices when ``[t]he device is intended for a use different from its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent;''.

   FDA believes that devices that have an intended use that differs from any legally marketed device should not be exempt because those devices present a potential unreasonable risk of illness or injury because their safety and effectiveness characteristics are unknown. Manufacturers of such devices should submit a premarket notification and the agency will determine if they are substantially equivalent to other legally marketed devices in that generic device type.

   In addition to the general limitations on exemptions that FDA considers applicable to all class I devices that are described previously, FDA also considers certain devices within a generic class to remain subject to the premarket notification requirements because they either are intended for a use that is of substantial importance in preventing impairment of human health or they present a potential unreasonable risk of illness or injury. For example, elsewhere in this document, FDA states that it considers liquid bandages generally to be exempt from the premarket notification requirements, but considers a subcategory of those devices, those intended for treatment of burns and other open wounds, to remain subject to the premarket notification requirements. FDA believes that liquid bandages intended for burns and other open wounds should remain subject to this requirement because they are of substantial importance in preventing impairment of human health by helping to prevent infections.

   FDA also advises that an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation.

3. Analysis of Comments to the February 2, 1998, Notice

   1. One comment proposed that general purpose instruments (21 CFR 862.2140, 862.2150, 862.2160, 862.2170, 862.2250, 862.2260, 862.2300, 862.2400, 862.2500, 862.2540, 862.2560, 862.2680, 862.2700, 862.2730, and 862.2750) designed to perform clinical testing that provide results that are intended to be of ``substantial importance in preventing impairment of human health, or presents a potential risk of illness or injury'' should not be exempt.

      If these devices are not subject to the proposed limitations in Sec. 862.9, FDA does not believe that premarket notification is necessary because these devices do not meet the reserved criteria. Laboratory instruments, like other devices, should be regulated according to risk and the risk associated with any device is related to intended use and indications for use. As general purpose instruments, these devices make no specific claims and their safety and effectiveness can be reasonably assured by using other general controls, including design controls (if the instrument includes computer automation). If the labeling includes indications for specific analytes on the general purpose instrument, the devices would not meet the reserved criteria. Under proposed Sec. 862.9, these devices would be subject to the limitations on exemptions and, therefore, would be not be exempt from premarket notification. Review of the system and its indications by FDA would be required through a new premarket notification.

   2. One comment stated that general purpose instruments should not be exempt from premarket notification because they could be used in a physician's office or near patient testing (point of care) by nonlaboratory trained individuals resulting in major threats to patient health.

      FDA believes that these concerns are addressed by the limitations on exemptions. Under Sec. 862.9(c), devices that are ``for near patient testing (point of care)'' would be excluded from exemption from premarket notification.

   3. One comment stated that in vitro devices ``intended for use in screening or diagnosis of familial and acquired genetic disorders including inborn errors of metabolism'' (21 CFR 862.1330, 862.1335, 862.1560, 862.1595, and 862.1650) and test markers for endocrine disorders (21 CFR 862.1075, 862.1080, 862.1200, 862.1245, 862.1250, 862.1260, 862.1265, 862.1270, 862.1275, 862.1280, 862.1285, 862.1300, 862.1370, 862.1385, 862.1390, 862.1395, and 862.1620) should be subject to premarket notification.

      FDA agrees that the manufacturer of the IVD's described by the comment may continue to be required to submit 510(k)'s under the proposed limitations on exemptions. Proposed limitations in Sec. 862.9 would assure that these products will be subject to premarket notification requirements if intended for use in screening or diagnosis of familial or

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      acquired genetic disorders or endocrine disorders and will not be subject to these requirements where the same device is not intended for these specific high risk indications. FDA, therefore, believes that these devices should be exempt from premarket notification, subject to the limitation.

   4. One comment suggested that premarket notifications and review should be required for devices and tests designed to ``identify or infer the identity of a microorganism directly from clinical materials,'' including devices classified under Secs. 866.3145, 866.3375, 866.3405, 866.3480, 866.3500 and 866.3740.

      FDA agrees. The comment has described one of the limitations on exemptions in the proposed rule. That limitation would apply to a number of classifications, including those cited by this comment.

   5. One comment suggested that:

      Quality control material--(assayed and unassayed) ([21 CFR] 862.1660), must continue to be reviewed so that the FDA oversight function may continue to identify those manufacturers of quality control reagents whose manufacturing or testing practices could fail to ensure a product of appropriate accuracy, stability, and reliability.

      FDA agrees that quality control materials are of critical importance in laboratory operations. The agency intends to continue to review assayed quality control materials because it believes they meet the reserved criteria. FDA believes unassayed quality control materials, other than those used for donor screening, are appropriate for exemption from premarket review. Unlike unassayed quality control materials, assayed quality control materials have specifically labeled performance levels that are reviewed. The performance of unassayed quality control materials that are not labeled is not assessed in the 510(k) process and is assessed by the laboratory rather than the manufacturer. Issues such as stability and reliability for unassayed quality control materials are adequately addressed by the new quality systems requirements of current good manufacturing practices. Unassayed quality control materials for donor screening, however, should not be exempt because FDA should review the labeling to ensure no specific performance claims are made.

   6. One comment indicated that there is an inconsistency between the exemptions of the free tyrosine test system (21 CFR 862.1730) and the galactose test system (21 CFR 862.1310), and the limitations on exemptions that apply to a device that ``(c) is a in-vitro device that is intended: * * * (2) for use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism,'' because all free tyrosine test systems and galactose test systems are for those uses. Another comment stated that they were confused about the exemption from premarket notification of free tyrosine test systems and the limitations on exemptions, as noted previously.

      FDA agrees there was an inconsistency. Because the devices are used for screening and diagnosis of genetic disorders and are related to significant morbidity and mortality associated with the disease entities identified by abnormalities in tyrosine and galactose metabolism, FDA believes these devices fit within the reserved criteria and should be added to the list of reserved class I devices that will continue to require premarket notification submissions.

   7. The Health Care Financing Administration (HCFA) raised concerns about the effect that exemptions may have on HCFA's implementation of the Clinical Laboratory Improvements Amendments (CLIA). HCFA subsequently commented that they believed that their concerns could be addressed without affecting the exemption process.

      FDA intends to continue to meet with the HCFA staff to address these concerns, which relate to inspection procedures in laboratories.

   8. One comment stated that FDA had previously exempted the unscented menstrual pad Sec. 884.5435 (21 CFR 884.5435), from premarket notification, except for intralabial pads and reusable menstrual pads. The comment pointed out that the February 2, 1998, notice did not state whether these devices were reserved or exempted. The comment believes that FDA meant to exempt them and asked for clarification.

      FDA has evaluated the use of intralabial pads and reusable menstrual pads and believes that they do meet the reserved criteria of FDAMA. These devices may present a potential unreasonable risk of illness or injury due to the risk of vaginal laceration, ulceration, vaginal microflora changes, and other possible adverse effects. FDA is, therefore, proposing to continue to designate the intralabial pads and reusable menstrual pads (Sec. 884.5435) as devices that require premarket notification.

   9. One comment stated that FDA should exempt calipers because they do not meet the class I reserved criteria of FDAMA.

      FDA concurs and notes that calipers were exempted on April 5, 1989 (54 FR 13826), under 21 CFR 878.4800 (manual surgical instrument for general use), subject to 21 CFR 878.9 limitations of exemptions from section 510(k) of the act.

   10. Two comments expressed support for FDA's interpretation of section 510(l) of FDAMA and the agency's conclusion that devices identified in 21 CFR 874.3300(b)(1), air conduction hearing aids, meet the exemption criteria. One comment stated that ``a device will lose its exemption if its intended use differs, or if it operates with a different fundamental scientific technology.'' The other comment added that the society he represented had concerns regarding FDA's ``vigilance in insisting on adherence to FDA regulation governing the labeling and conditions for sale of hearing aids.''

       FDA agrees with the one comment on the scope of the limitations on exemptions. As far as FDA regulations governing the labeling, the agency believes that general controls are sufficient to regulate air- conduction hearing aids and that trade complaints will keep the agency well informed. The proposed regulation on conditions of sale of hearing aids is moving toward publication.

   11. One comment responded to the February 2, 1998, notice by submitting a request for classification under section 513(g) of the act, requesting information regarding the requirements applicable to a dental water filter system with a treated filter/waterline under 21 CFR 872.6640.

       FDA considers this comment a section 513(g) of the act request and will respond to the submitter in an individual response.

   12. One comment requested that the 510(k) the comment submitted for a class I device classified under Sec. 884.1040 (21 CFR 884.1040) Viscometer for cervical mucus, be found to be exempt from the section 510(k) requirements of the act. The comment stated that ``the device is not intended for a use which is of substantial importance in preventing impairment of human health and does not present a potential unreasonable risk of illness or injury (``reserved criteria'')'' and should not be placed under the reserved criteria found in section 206 of FDAMA.

       FDA agrees that, generally, viscometers for cervical mucus (Sec. 884.1040) do not meet the ``reserved'' criteria under FDAMA and did place this classification regulation on the list of exempted devices in the February 2, 1998, notice. Consistent with the February 2, 1998, notice, FDA is proposing to designate viscometers for cervical use exempt from 510(k) requirements. The comment's device,

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       however, would use a new matrix for this device. FDA believes that this represents a different intended use that would make this device subject to the limitations on exemptions and, therefore, ineligible for exemption.

   13. One comment questioned the limitations on exemptions stated in the February 2, 1998, notice, particularly the limitations applicable to IVD's that are noninvasive tests. The comment criticized the use of the words ``noninvasive testing'' as being overly broad.

       FDA disagrees with this comment. FDA believes that the limitations are necessary to assure that devices are not marketed that are significantly different from the devices exempted from premarket notification, particularly in the area of IVD's where devices are often subject to changes in intended use and conditions of use. Noninvasive testing devices should not be exempt because they almost always involve novel matrices and novel technologies. However, FDA is clarifying the phrase, ``noninvasive testing,'' by citing the definition of ``noninvasive'' found in Sec. 812.3(k) in the proposed limitations on exemptions.

   14. One comment suggested that FDA should review the exemptions and reservations in existing classifications to assure that the present lists are consistent with those listed in the February 2, 1998, notice.

       FDA has reviewed the existing regulations again and is proposing to reserve five currently exempted device classifications (Secs. 862.3750, 862.3850, 870.4200, 886.4750, and 890.1175).

   15. One comment suggested that FDA reserve 11 class I devices that FDA stated it considered exempt class I devices in the February 2, 1998, Federal Register notice and subject them to section 510(k) of the act requirements, including: Cultured animal and human cells (21 CFR 864.2280); Microorganism differentiation and identification device (21 CFR 866.2660); Coxsackievirus serological reagents (21 CFR 866.3145); Echinococcus spp. serological reagents (21 CFR 866.3200); Equine encephalomyelitis virus serological reagents (21 CFR 866.3240); Lymphocytic choriomeningitis virus serological reagents (21 CFR 866.3360); Mumps virus serological reagents (21 CFR 866.3380); Poliovirus serological reagents (21 CFR 866.3405); Trichinella spiralis serological reagents (21 CFR 866.3850); Rickettsia serological reagents (21 CFR 866.3500); and Streptococcus spp. serological reagents (21 CFR 866.3740).

       FDA does not agree with the comment that these devices meet the reserved criteria. FDA notes the limitations on exemptions are specifically designed to maintain premarket review for devices used in ``screening, diagnosis, or monitoring life threatening diseases'' or ``to infer the identity of a microorganism directly from clinical material.'' While section 510(k) of the act exemptions would apply to devices marketed for uses the agency would consider lower risk, such as determination of immune status or for epidemiological uses of these devices, they would not apply to devices with diagnostic claims for use in life-threatening disease states or for direct detection of a microorganism using clinical material. Therefore, FDA is proposing to designate these 11 devices as exempt from section 510(k) of the act requirements subject to the limitations on exemptions.

   16. One comment suggested that the limitations on exemptions are unnecessary, confusing, and difficult to apply, especially to IVD's. This comment additionally notes ``we question the basis for FDA's broad restrictions in such a specific category of devices.''

       FDA does not agree that the language is unnecessary, confusing, or difficult to apply. The limitations language that was in the February 2, 1998, Federal Register notice, and that is proposed for all class I devices modifies the limitations on exemptions currently found in Sec. ______.9 of each device classification regulation part (e.g., Secs. 862.9, 864.9, etc.) only in three ways. First, FDA has referenced class II devices to reflect that both class I and class II devices may be exempted in accordance with new section 510(l) and (m). Second, the limitations language modifies current limitations language by stating that devices are to be compared to ``any legally marketed device in that generic type of device'' rather than a device on the market ``before May 28, 1976'' or a ``preamendments device to which it has been determined substantially equivalent.'' Third, the limitations language adds specific language relating to IVD's. The agency cannot predict all possible different intended uses or changes in fundamental scientific technologies that may significantly affect safety and effectiveness; limitations on exemptions are, therefore, in the best interest of the public health because they ensure that devices incorporating such changes will be reviewed for safety and effectiveness by the agency before they go to market.

       In order to efficiently allocate review resources, the agency has developed a risk-based approach toward use of the limitations on exemptions to ensure that high-risk devices remain subject to premarket review. The limitations on exemptions continue to take into account two critical risk elements--intended use and novelty of technology.

       Furthermore, FDA believes that in vitro diagnostic devices are unique because their safety and effectiveness relates primarily to the information generated by these devices rather than the direct interaction between device and patient. FDA has more fully discussed the need for these limitations earlier in this document.

   17. One comment believed the limitations on exemptions required clarification as follows:

       With regard to the first limitation (``has an intended use that is different from the intended use of a legally marketed device in that generic type''), we believe that current law is clear that if a device has an intended use different than that expressed in the definition contained in the Code of Federal Regulations (CFR), such device would not be the same as the exempted device. The exemption would simply not apply to that device. However, ``intended use'' can encompass many different concepts that go beyond the general intended use statements that comprised the CFR definitions. There has been some controversy, for instance, over the extent to which indications for use can change intended use. Our position is that any indication for use that has been included in a previous 510(k) order of classification identifies the scope of the intended use for each exempt type of device. Minor variances of indications for use within the intended use of an exempt type of device should have no effect on the status of a 510(k) exemption.

       FDA has interpreted Sec. ______.9(a) in the limitations on exemptions under the current regulations to mean that any legally marketed device (as defined in 21 CFR 807.92(a)(3)) within a device classification regulation may serve as a predicate for another manufacturer's device and the other manufacturer's device may be exempt. FDA believes that any additional indication for use for an exempt classification device type (i.e., an indication not previously cleared) is considered a different intended use and does not meet the limitations on exemptions, and therefore, requires a new premarket notification. FDA agrees that minor variances in indications would not affect the exemption status of the classification. FDA notes that in its guidance entitled ``Deciding When to Submit a 510(k) for a Change to an Existing Device,'' FDA states, in regard to minor variances in indications of closely related populations, ``If the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential for complications as the original, then a new 510(k) is not ordinarily expected.''

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   18. On its own initiative, FDA is proposing to require premarket notification for five devices that are currently exempt from premarket notification: Quinine test system (Sec. 862.3750), sulfonamide test system (Sec. 862.3850), cardiopulmonary bypass accessory equipment (Sec. 870.4200), electrode cable (Sec. 890.1175), and ophthalmic eye shield (when made of other than plastic or aluminum) (Sec. 886.4750).

4. FDA Proposal to Revoke Exemptions

   1. Quinine Test System (Sec. 862.3750) and Sulfonamide Test System (Sec. 862.3850)

      On June 8, 1988 (53 FR 21447), FDA published a final rule exempting the quinine test system and the sulfonamide test system from premarket notification requirements. FDA stated that it was exempting these products because it believed that premarket notification was not necessary to protect the public health.

      The quinine test system is used to measure quinine, a fever- reducing and pain-relieving drug used to treat malaria, in the serum or urine. Measurements obtained by this device are used in the diagnosis and treatment of quinine overdose and malaria. If this device fails, persons who have malaria may suffer serious life-threatening consequences by not receiving the appropriate amount of quinine. Similarly, the sulfonamide test system is intended to measure sulfonamide levels which are used to treat life-threatening bacterial infections. The failure of this device may also result in the improper treatment of a life-threatening disease.

      Given that these devices are used in determining the treatments for life-threatening diseases, and an inaccurate measurement of the treatment drug could result in life-threatening consequences, FDA does not believe that its previous determinations to exempt these devices from premarket notification were correct. Accordingly, FDA believes that premarket review is necessary to assure the safety and effectiveness of these devices. Moreover, FDA believes that these products meet the reserved criteria for premarket review under section 510(l), in that they are intended for a use which is of substantial importance in preventing impairment of human health, and present a potential unreasonable risk of illness or injury. Therefore, FDA is proposing to require manufacturers of these products to submit premarket notifications.

   2. Ophthalmic Eye Shields (Sec. 886.4750)

      On September 2, 1987 (52 FR 33366), FDA published a final rule classifying ophthalmic eye shields as class I devices. This generic type of device is described in Sec. 886.4750 as ``a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.'' Plastic or aluminum eye shields rest over the forehead and cheek and do not contact the eye.

      Since that classification, FDA has found eye shields that are made of collagen substantially equivalent to eye shields made out of plastic or aluminum in Sec. 886.4750. Collagen eye shields, unlike aluminum and plastic eye shields, come in direct contact with the cornea and are indicated for relief of discomfort from post-surgical, traumatic and nontraumatic corneal conditions. Unlike aluminum and plastic eye shields, there are toxicological concerns relating to biocompatibility and dissolving time for collagen materials. In premarket reviews, FDA has examined biocompatibility and dissolving issues in determining the substantial equivalence of collagen eye shields to plastic and aluminum eye shields.

      On December 7, 1994 (59 FR 63005), FDA published a final rule exempting this classification from premarket notification requirements, and quality systems requirements, except 21 CFR 820.198, with respect to complaint files. FDA erred in not amending the codified language at that time to retain premarket review and quality system requirements for collagen eye shields that had been placed in that classification. Despite the exemption language, FDA has continued to receive and review premarket notifications for eye shields made out of collagen.

      Because the toxicological issues cause the product to meet the reserved criteria in that the devices are intended for a use which is of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury, FDA is proposing to amend the codified text to state that collagen eye shields are not exempt from premarket notification requirements.

   3. Cardiopulmonary Bypass Accessory Equipment (Sec. 870.4200) and Electrode Cable (Sec. 890.1175)

      On June 12, 1989 (54 FR 25042), FDA published a final rule exempting electrode cables (Sec. 890.1175) and cardiopulmonary bypass accessory equipment (Sec. 870.4200) from premarket notification requirements. FDA received numerous reports of deaths and injuries associated with unprotected patient cables and lead wires. To address the risk of patient exposure to macro shock or electrocution due to the inappropriate connection of a patient connected cable or electrode lead wire to an alternating current power source, in the Federal Register of May 9, 1997 (62 FR 25477), FDA published a final rule establishing a performance standard for cables and leads. In the preamble of that final rule, FDA announced that it intended to reclassify electrode cables (Sec. 890.1175) and cardiopulmonary bypass accessory equipment (Sec. 870.4200) to class II to subject them to this performance standard. In the meantime, FDA is proposing to subject these devices to premarket review to assure that they are safe and effective, pending the rulemaking to reclassify them into class II.

5. Proposed Designation of Devices

   In the Federal Register of February 2, 1998 (63 FR 5387), FDA issued a notice of its intent to propose to exempt a list of class I (general controls) devices from the requirement of premarket notification, subject to the limitations of exemptions. FDA has reviewed that list and other devices in light of the comments received in response to the February 2, 1998, notice and other information that has come to FDA's attention. As a result, FDA is proposing to designate as exempt certain devices that were not listed as exempt in the February 2, 1998, notice and to designate as reserved devices certain devices that were not designated as reserved in the February 2, 1998, notice or that were previously exempted by regulation.

   The following devices are devices that FDA believes meet the reserved criteria in section 206 of FDAMA and, therefore, FDA is proposing to designate that they remain subject to premarket notification under new section 510(l) added to the act:

   [[Page 63228]]

   Table 1.--Proposed Designations of Reserved Class I Devices

   21 CFR Section

   Name of Device

   862.1065

   Ammonia test system 862.1113

   Bilirubin (total and unbound) in the neonate test system 862.1310

   Galactose test system 862.1410

   Iron (non-heme) test system 862.1415

   Iron-binding capacity test system 862.1495

   Magnesium test system 862.1580

   Phosphorous (inorganic) test system 862.1660

   Quality control material (assayed and unassayed)‹SUP›1 862.1680

   Testosterone test system 862.1730

   Free tyrosine test system 862.1775

   Uric acid test system 862.3050

   Breath-alcohol test system 862.3110

   Antimony test system 862.3120

   Arsenic test system 862.3220

   Carbon monoxide test system 862.3240

   Cholinesterase test system 862.3280

   Clinical toxicology control material (assayed and unassayed)‹SUP›1 862.3600

   Mercury test system 862.3750

   Quinine test system 862.3850

   Sulfonamide test system 864.7040

   Adenosine triphosphate release assay 864.8950

   Russell viper venom reagent 864.9050

   Blood bank supplies 864.9125

   Vacuum-assisted blood collection system‹SUP›2 864.9195

   Blood mixing devices and blood weighing devices‹SUP›2 866.2390

   Transport culture medium 866.2560

   Microbial growth monitor‹SUP›3 866.2850

   Automated zone reader 866.2900

   Microbiological specimen collection and transport device 866.3110

   Campylobacter fetus serological reagents 866.3120

   Chlamydia serological reagents 866.3235

   Epstein-Barr virus serological reagents 866.3370

   Mycobacterium tuberculosis immunofluorescent reagents 866.3870

   Trypanosoma spp. serological reagents 870.4200

   Cardiopulmonary bypass accessory equipment 872.3700

   Dental mercury 872.4200

   Dental handpiece and accessories 872.6250

   Dental chair and accessories‹SUP›4 872.6640

   Dental operative unit and accessories‹SUP›5 872.6710

   Boiling water sterilizer 876.5160

   Urological clamps for males‹SUP›6 878.4460

   Surgeon's glove 880.5090

   Liquid bandage‹SUP›7 880.5680

   Pediatric position holder 880.6250

   Patient examination glove 880.6375

   Patient lubricant 880.6760

   Protective restraint 882.1030

   Ataxiagraph 882.1420

   Electroencephalogram (EEG) signal spectrum analyzer 882.4060

   Ventricular cannula‹SUP›8 882.4545

   Shunt system implantation instrument‹SUP›9 884.2980(a)

   Telethermographic system‹SUP›10 884.2982(a)

   Liquid crystal thermographic system‹SUP›11 884.5435

   Unscented menstrual pads (intralabial pads and reusable menstrual pads) 886.4070

   Powered corneal burr‹SUP›12 886.4300

   Intraocular lens guide‹SUP›13 886.4370

   Keratome 886.4750

   Ophthalmic eye shield (when made of other than plastic or aluminum) 888.1500

   Goniometer 890.1175

   Electrode cable 890.3850

   Mechanical wheelchair 890.5710

   Hot or cold disposable pack‹SUP›14 892.1100

   Scintillation (gamma) camera 892.1110

   Positron camera

   \1\ Meets reserved criteria for all assayed and only the unassayed when used for donor screening. \2\ Meets reserved criteria when automated. \3\ Meets reserved criteria when automated blood culturing systems. \4\ Meets reserved criteria when dental chair with the operative unit. \5\ Meets reserved criteria when it is not an accessory to the unit. \6\ Meets reserved criteria when devices are for internal use or are used for females. \7\ Meets reserved criteria for uses other than as a skin protectant. \8\ Meets reserved criteria if not made of surgical grade stainless steel.

   [[Page 63229]]

   \9\ Meets reserved criteria if not made of surgical stainless steel. \10\ Meets reserved criteria if an adjunct use system. \11\ Meets reserved criteria if nonelectrically powered and AC-powered adjunctive system. \12\ Meets reserved criteria if for use other than for removing rust rings. \13\ Meets reserved criteria if used as folders and injectors for soft or foldable intraocular lenses (IOL's). \14\ Meets reserved criteria if indicated for use on infants.

   FDA is proposing to amend the regulations to designate the following devices as exempt from premarket notification because FDA believes that they do not meet the reserved criteria under section 206 of the FDAMA that adds new section 510(l) of the act:

   Table 2.--Proposed Designations of Exempted Class I Devices

   21 CFR Section

   Name of Device

   862.1030

   Alanine amino transferase (ALT/SGPT) test system 862.1040

   Aldolase test system 862.1060

   Delta-aminolevulinic acid test system 862.1075

   Androstenedione test system 862.1080

   Androsterone test system 862.1095

   Ascorbic acid test system 862.1115

   Urinary bilirubin and its conjugates (nonquantitative) test system 862.1130

   Blood volume test system 862.1135

   C-peptides of proinsulin test system 862.1165

   Catecholamines (total) test system 862.1175

   Cholesterol (total) test 862.1180

   Chymotrypsin test system 862.1185

   Compound S (11-deoxycortisol) test system 862.1195

   Corticoids test system 862.1200

   Corticosterone test system 862.1240

   Cystine test system 862.1245

   Dehydroepiandrosterone (free and sulfate) test system 862.1250

   Desoxycorticosterone test system 862.1260

   Estradiol test system 862.1265

   Estriol test system 862.1270

   Estrogens (total, in pregnancy) test system 862.1275

   Estrogens (total, nonpregnancy) test system 862.1280

   Estrone test system 862.1285

   Etiocholanolone test system 862.1300

   Follicle-stimulating hormone test system 862.1325

   Gastrin test system 862.1330

   Globulin test system 862.1335

   Glucagon test system 862.1360

   Gamma-glutamyl transpeptidase and isoenzymes test system 862.1370

   Human growth hormone test system 862.1375

   Histidine test system 862.1385

   17-Hydroxycorticosteroids (17-ketogenic steroids) test system 862.1390

   5-Hydroxyindole acetic acid/serotonin test system 862.1395

   17-Hydroxyprogesterone test system 862.1400

   Hydroxyproline test system 862.1405

   Immunoreactive insulin test system 862.1430

   17-Ketosteroids test system 862.1435

   Ketones (nonquantitative) test system 862.1450

   Lactic acid test system 862.1460

   Leucine aminopeptidase test system 862.1465

   Lipase test system 862.1475

   Lipoprotein test system 862.1485

   Luteinizing hormone test system 862.1500

   Malic dehydrogenase test system 862.1505

   Mucopolysaccharides (nonquantitative) test system 862.1510

   Nitrite (nonquantitative) test system 862.1520

   5'-Nucleotidase test system 862.1530

   Plasma oncometry test system 862.1535

   Ornithine carbamyl transferase test system 862.1540

   Osmolality test system 862.1542

   Oxalate test system 862.1550

   Urinary pH (nonquantitative) test system 862.1560

   Urinary phenylketones (nonquantitative) test system 862.1570

   Phosphohexose isomerase test system 862.1590

   Porphobilinogen test system 862.1595

   Porphyrins test system 862.1605

   Pregnanediol test system 862.1610

   Pregnanetriol test system 862.1615

   Pregnenolone test system 862.1620

   Progesterone test system 862.1625

   Prolactin (lactogen) test system

   [[Page 63230]]

   862.1630

   Protein (fractionation) test system 862.1645

   Urinary protein or albumin (nonquantitative) test system 862.1650

   Pyruvate kinase test system 862.1655

   Pyruvic acid test system 862.1660

   Quality control material (assayed and unassayed)‹SUP›1 862.1705

   Triglyceride test system 862.1725

   Trypsin test system 862.1780

   Urinary calculi (stones) test system 862.1785

   Urinary urobilinogen (nonquantitative) test system 862.1790

   Uroporphyrin test system 862.1795

   Vanilmandelic acid test system 862.1805

   Vitamin A test system 862.1820

   Xylose test system 862.2140

   Centrifugal chemistry analyzer for clinical use 862.2150

   Continuous flow sequential multiple chemistry analyzer for clinical use 862.2160

   Discrete photometric chemistry analyzer for clinical use 862.2170

   Micro chemistry analyzer for clinical use 862.2250

   Gas liquid chromatography system for clinical use 862.2260

   High pressure liquid chromatography system for clinical use 862.2270

   Thin-layer chromatography system for clinical use 862.2300

   Colorimeter, photometer, or spectrophotometer for clinical use 862.2400

   Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use 862.2500

   Enzyme analyzer for clinical use 862.2540

   Flame emission photometer for clinical use 862.2560

   Fluorometer for clinical use 862.2680

   Microtitrator for clinical use 862.2700

   Nephelometer for clinical use 862.2730

   Osmometer for clinical use 862.2750

   Pipetting and diluting system for clinical use 862.2850

   Atomic absorption spectrophotometer for clinical use 862.2860

   Mass spectrometer for clinical 862.2900

   Automated urinalysis system 862.3280

   Clinical toxicology control material (assayed and unassayed)‹SUP›1 864.2280

   Cultured animal and human cells 864.3250

   Specimen transport and storage container 864.5240

   Automated blood cell diluting apparatus 864.6150

   Capillary blood collection tube 864.9125

   Vacuum-assisted blood collection system‹SUP›2 864.9185

   Blood grouping view box 864.9195

   Blood mixing devices and blood weighing devices‹SUP›2 864.9225

   Cell-freezing apparatus and reagents for in vitro diagnostic use 864.9275

   Blood bank centrifuge for in vitro diagnostic use 864.9320

   Copper sulphate solution for specific gravity determinations 864.9750

   Heat-sealing device 866.2660

   Microorganism differentiation and identification device 866.3040

   Aspergillus spp. serological reagents 866.3140

   Corynebacterium spp. serological reagents 866.3145

   Coxsackievirus serological reagents 866.3200

   Echinococcus spp. serological reagents 866.3240

   Equine encephalomyelitis virus serological reagents 866.3355

   Listeria spp. serological reagents 866.3360

   Lymphocytic choriomeningitis virus serological reagents 866.3375

   Mycoplasma spp. serological reagents 866.3380

   Mumps virus serological reagents 866.3405

   Poliovirus serological reagents 866.3480

   Respiratory syncytial virus serological reagents 866.3500

   Rickettsia serological reagents 866.3600

   Schistosoma spp. serological reagents 866.3680

   Sporothrix schenckii serological reagents 866.3740

   Streptococcus spp. serological reagents 866.3850

   Trichinella spiralis serological reagents 866.5060

   Prealbumin immunological test system 866.5065

   Human allotypic marker immunological test system 866.5160

   Beta-globulin immunological test system 866.5200

   Carbonic anhydrase B and C immunological test 866.5330

   Factor XIII, A, S, immunological test system‹SUP›3 866.5400

   Alpha-globulin immunological test system 866.5420

   Alpha-1-glycoproteins immunological test system 866.5425

   Alpha-2-glycoproteins immunological test system 866.5430

   Beta-2-glycoprotein I immunological test system 866.5440

   Beta-2-glycoprotein III immunological test system

   [[Page 63231]]

   866.5560

   Lactic dehydrogenase immunological test system 866.5570

   Lactoferrin immunological test system 866.5590

   Lipoprotein X immunological test system 866.5715

   Plasminogen immunological test system 866.5735

   Prothrombin immunological test system‹SUP›4 866.5765

   Retinol-binding protein immunological test system 866.5890

   Inter-alpha trypsin inhibitor immunological test system 868.1910

   Esophageal stethoscope 868.5620

   Breathing mouthpiece 868.5640

   Medicinal nonventilatory nebulizer (atomizer) 868.5675

   Rebreathing device 868.5700

   Nonpowered oxygen tent 868.6810

   Tracheobronchial suction catheter 872.3275(a)(1)

   Dental cement (zinc oxide-eugenol) 872.3400(b)(1)

   Karaya and sodium borate with or without acacia denture adhesive (less than 12 percent sodium borate by weight) 872.3540(b)(1)

   OTC denture cushion or pad‹SUP›5 872.6300

   Rubber dam‹SUP›6 872.6390

   Dental floss 874.1070

   Short increment sensitivity index (SISI) adapter 874.1100

   Earphone cushion for audiometric testing 874.1500

   Gustometer 874.1800

   Air or water caloric stimulator 874.1925

   Toynbee diagnostic tube 874.3300(b)(1)

   Hearing aid‹SUP›6 874.3540

   Prosthesis modification instrument for ossicular replacement surgery 874.4100

   Epistaxis balloon 874.4420

   Ear, nose, and throat manual surgical instrument 874.5300

   Ear, nose, and throat examination and treatment unit 874.5550

   Powered nasal irrigator 874.5840

   Antistammering device 876.5160

   Urological clamp for males‹SUP›7 876.5210

   Enema kit 876.5250(b)(2)

   Urine collector and accessories‹SUP›8 876.5980(b)(2)

   Gastrointestinal tube and accessories‹SUP›9 878.3250

   External facial fracture fixation appliance 878.3910

   Noninflatable extremity splint 878.3925

   Plastic surgery kit and accessories 878.4040

   Surgical apparel‹SUP›10 878.4100

   Organ bag 878.4200

   Introduction/drainage catheter and accessories 878.4320

   Removable skin clip 878.4680

   Nonpowered, single patient, portable suction apparatus 878.4760

   Removable skin staple 878.4820

   Surgical instrument motors and accessories/attachments 878.4960

   Operating tables and accessories and operating chairs and accessories 880.5090

   Liquid bandage‹SUP›11 880.5270

   Neonatal eye pad 880.5420

   Pressure infusor for an I.V. bag 882.1200

   Two-point discriminator 882.1500

   Esthesiometer 882.1750

   Pinwheel 882.4060

   Ventricular cannula‹SUP›12 882.4545

   Shunt system implantation instrument‹SUP›13 882.4650

   Neurosurgical suture needle 882.4750

   Skull punch‹SUP›14 884.1040

   Viscometer for cervical mucus 886.1780

   Retinoscope‹SUP›15 886.1940

   Tonometer sterilizer 886.4070

   Powered corneal burr‹SUP›16 886.4300

   Intraocular lens guide‹SUP›17 886.5850

   Sunglasses (nonprescription 890.5180

   Manual patient rotation bed 890.5710

   Hot or cold disposable pack‹SUP›18 892.1300

   Nuclear rectilinear scanner 892.1320

   Nuclear uptake probe 892.1330

   Nuclear whole body scanner 892.1350

   Nuclear scanning bed 892.1410

   Nuclear electrocardiograph synchronizer 892.1890

   Radiographic film illuminator 892.1910

   Radiographic grid 892.1960

   Radiographic intensifying screen

   [[Page 63232]]

   892.1970

   Radiographic ECG/respirator, synchronizer 892.2010

   Medical image storage device 892.2020

   Medical image communication device 892.5650

   Manual radionuclide applicator system 892.6500

   Personnel protective shield

   \1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests. \2\ Exemption is limited to manual devices. \3\ This exemption should not be confused with 21 CFR 864.7290. \4\ This exemption should not be confused with 21 CFR 864.5425 or 864.7750. \5\ This exemption does not apply to class III OTC denture cushion as described in 21 CFR 872.3540(b)(2). \6\ Exemption does not include rubber dam intended for use in preventing transmission of sexually transmitted diseases through oral sex. Those devices are classified as condoms in Sec. 884.5300. \7\ Exemption is limited to air-conduction hearing aids. \8\ Exemption does not include devices for internal use or devices used for females. \9\ Exemption does not include class II devices for a urine collector and accessories intended to be connected to an indwelling catheter as described in 21 CFR 876.5250(b)(1). \10\ Exemption is limited to dissolvable nasogastric feed tube guide for the nasogastric tube in Sec. 876.5980(b)(2) (21 CFR 876.5980(b)(2)). Exemption does not include class II devices as described in Sec. 876.5980(b)(1). \11\ Exemption is limited to class I category other than surgical gowns and surgical masks. \12\ Exemption is limited to uses as a skin protectant. \13\ Exemption is limited to devices made of surgical grade stainless steel. \14\ Exemption is limited to devices made of surgical grade stainless steel. \15\ Exemption should not be confused with 21 CFR 882.4305. \16\ Exemption is limited to class I battery-powered devices. \17\ Exemption is limited to rust ring removal. \18\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.

6. Differences Between the February 2, 1998, List of Exempt and Reserved Devices, and List of Exempt and Reserved Devices Proposed Herein

   As stated previously, FDA issued a notice on February 2, 1998, in the Federal Register that listed the devices that it considered exempt from 510(k) requirements (exempt), and those it considered subject to 510(k) requirements (reserved) under new section 510(l). This document proposes to designate the reserved and exempt lists by notice and comment rulemaking. Although most of the device categories listed in the February 2, 1998, notice, and the device categories listed in this proposal are identical, there are a few differences. These differences are described in the following lists:

   Table 3.--Proposed Reserved Devices That Are Currently Exempted by Regulation

   21 CFR Section

   Name of Device

   862.3750

   Quinine test system 862.3850

   Sulfonamide test system 870.4200

   Cardiopulmonary bypass accessory equipment 886.4750

   Ophthalmic eye shield (when made of other than plastic or aluminum) 890.1175

   Electrode cable

   Table 4.--Additional Proposed Reserved Devices Not Considered Reserved Under the February 2, 1998, Federal Register Notice

   21 CFR Section

   Name of Device

   862.3050

   Breath alcohol test system 872.3700

   Dental Mercury 884.5435

   Unscented menstrual pads (intralabial pads and reusable menstrual pads)

   Table 5.--Additional Proposed Exempted Devices Not Considered Exempted in the February 2, 1998, Federal Register Notice

   21 CFR Section

   Name of Device

   864.3250

   Specimen transport and storage container (OTC) 864.6150

   Capillary blood collection tube 872.3275(a)(1)

   Dental cement (zinc oxide-eugenol) 872.3540(b)(1)

   OTC dental cushion or pad (wax impregnated cotton cloth) 872.6300

   Rubber dam 874.1100

   Earphone cushion for audiometric testing 874.3540

   Prosthesis modification instrument for ossicular replacement surgery 874.4420

   Ear, nose, and throat manual surgical instrument 876.5980(b)(2)

   Gastrointestinal tube and accessories (dissolvable nasogastric feed tube guide for the nasogastric tube)

   [[Page 63233]]

   878.3250

   External facial fracture appliance 878.3910

   Noninflatable extremity splint 878.3925

   Plastic surgery kit and accessories 878.4100

   Organ bag 882.1200

   Two point discriminator 882.1500

   Esthesiometer 882.1750

   Pinwheel 892.1350

   Nuclear scanning bed 892.2010

   Medical image storage device 892.2020

   Medical image communication device 892.6500

   Personnel protective shield

7. Environmental Impact

   The agency has determined under 21 CFR 25.30(h) that these proposed actions are of a type that do not individually or cumudatave a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

8. Analysis of Impacts

   FDA has examined the impacts of the proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety and other advantages distributive impacts and equity). The agency believes that this proposed rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the proposed rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

   The Regulatory Flexibility Act requires, if a rule has a significant impact on a substantial number of small entities, agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. In most cases, the proposed rule would reduce a regulatory burden by exempting manufacturers of devices subject to the rule from the requirements of premarket notification.

   FDA is proposing to require premarket notification for 5 devices that were previously exempt from premarket notification. These devices are as follows:

   1. Cardiopulmonary Bypass Accessory Equipment (Sec. 870.4200) and Electrode Cable (Sec. 890.1175).

      In the Federal Register of May 9, 1997 (62 FR 25477), FDA published a final rule to establish a performance standard for electrode lead wires and patient cables. In the preamble to that rule (62 FR 25485), FDA noted that three unprotected cable and electrode lead wire systems are included in class I devices, and, as such, are not subject to a mandatory performance standard. These include the two devices listed previously and the AC-powered goniometer (21 CFR 888.1500). FDA further stated that, because of the degree of health risk, the agency intended to reclassify the devices into class II so that they would be subject to the mandatory performance standard. The cardiopulmonary bypass accessory equipment and the electrode cable were already exempt from premarket notification; the AC-powered goniometer was not. Because of the degree of health risk, FDA believes that these devices should be designated as reserved devices.

      FDA also included in the preamble of the May 9, 1997, rule an assessment of the economic impact of imposition of the standard including an assessment of its effect on small businesses. In this assessment, FDA included the three class I devices to which the rule would later apply. FDA concluded that the rule would not have a significant economic impact on a substantial number of small entities. This rule would only impose the additional requirement of submitting a premarket notification for these devices. Because the premarket notification would consist primarily of a certification of compliance with the cables and leads standard, FDA believes that this requirement will not be a significant burden.

   2. Ophthalmic Eye Shield (When Made of Other than Plastic or Aluminum) (Sec. 886.4750).

      There are six manufacturers of ophthalmic eye shields other than those made of plastic or aluminum registered with FDA. FDA anticipates that any premarket notifications that are necessary for these devices would be simple. FDA would be primarily interested in the biocompatibility of the devices. FDA estimates that preparation of such a premarket notification would cost no more than $5,000.

   3. Quinine Test System (Sec. 862.3750) and Sulfonamide test system (Sec. 862.3850).

      At this time, there are no firms registered for manufacture of these devices.

      In light of the previous discussion under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. The rule also does not trigger the requirement for a written statement under section 202(a) of the Unfunded Mandates Reform Act because it does not impose a mandate that results in an expenditure of $100 million or more by State, local, or tribal governments in the aggregate, or by the private sector, in any 1 year.

9. Paperwork Reduction Act of 1995

   FDA tentatively concludes that this proposed rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

10. Comments

    Interested persons may, on or before January 26, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted except that individuals may submit one copy.

    [[Page 63234]]

    Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

    List of Subjects

    21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890

    Medical devices.

    21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, FDA is proposing to amend 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 as follows:

    PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation for 21 CFR part 862 continues to read as follows:

       Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 862.9 is revised to read as follows:

       Sec. 862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

       The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

       (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

       (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

       (c) The device is an in vitro device that is intended:

       (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

       (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases;

       (5) For use in diabetes management;

       (6) For identifying or inferring the identity of a microorganism directly from clinical material;

       (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

       (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

       (9) For near patient testing (point of care).

    3. Section 862.1030 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1030 Alanine amino transferase (ALT/SGPT) test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    4. Section 862.1040 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1040 Aldolase test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    5. Section 862.1060 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1060 Delta-aminolevulinic acid test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    6. Section 862.1075 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1075 Androstenedione test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    7. Section 862.1080 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1080 Androsterone test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    8. Section 862.1095 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1095 Ascorbic acid test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    9. Section 862.1115 is amended by revising paragraph (b) to read as follows:

       Sec. 862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.

       * * * * *

       (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    10. Section 862.1130 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1130 Blood volume test system.

        * * * * *

        [[Page 63235]]

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    11. Section 862.1135 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1135 C-peptides of proinsulin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    12. Section 862.1165 is amended by revising paragraph (b) to read follows:

        Sec. 862.1165 Catecholamines (total) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    13. Section 862.1175 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1175 Cholesterol (total) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    14. Section 862.1180 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1180 Chymotrypsin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    15. Section 862.1185 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1185 Compound S (11-deoxycortisol) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    16. Section 862.1195 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1195 Corticoids test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    17. Section 862.1200 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1200 Corticosterone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    18. Section 862.1240 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1240 Cystine test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    19. Section 862.1245 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1245 Dehydroepiandrosterone (free and sulfate) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    20. Section 862.1250 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1250 Desoxycorticosterone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    21. Section 862.1260 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1260 Estradiol test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    22. Section 862.1265 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1265 Estriol test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    23. Section 862.1270 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1270 Estrogens (total, in pregnancy) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    24. Section 862.1275 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1275 Estrogens (total, nonpregnancy) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    25. Section 862.1280 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1280 Estrone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    26. Section 862.1285 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1285 Etiocholanolone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    27. Section 862.1300 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1300 Follicle-stimulating hormone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    28. Section 862.1325 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1325 Gastrin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    29. Section 862.1330 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1330 Globulin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    30. Section 862.1335 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1335 Glucagon test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in

        [[Page 63236]]

        subpart E of part 807 of this chapter subject to Sec. 862.9.

    31. Section 862.1360 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    32. Section 862.1370 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1370 Human growth hormone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    33. Section 862.1375 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1375 Histidine test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    34. Section 862.1385 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    35. Section 862.1390 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1390 5-Hydroxyindole acetic acid/serotonin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    36. Section 862.1395 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1395 17-Hydroxyprogesterone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    37. Section 862.1400 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1400 Hydroxyproline test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    38. Section 862.1405 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1405 Immunoreactive insulin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    39. Section 862.1430 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1430 17-Ketosteroids test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    40. Section 862.1435 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1435 Ketones (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    41. Section 862.1450 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1450 Lactic acid test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    42. Section 862.1460 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1460 Leucine aminopeptidase test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    43. Section 862.1465 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1465 Lipase test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    44. Section 862.1475 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1475 Lipoprotein test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    45. Section 862.1485 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1485 Luteinizing hormone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    46. Section 862.1500 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1500 Malic dehydrogenase test system.

        * * * * * (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    47. Section 862.1505 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1505 Mucopolysaccharides (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    48. Section 862.1510 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1510 Nitrite (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    49. Section 862.1520 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1520 5'-Nucleotidase test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    50. Section 862.1530 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1530 Plasma oncometry test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the

        [[Page 63237]]

        premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    51. Section 862.1535 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1535 Ornithine carbamyl transferase test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    52. Section 862.1540 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1540 Osmolality test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    53. Section 862.1542 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1542 Oxalate test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    54. Section 862.1550 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1550 Urinary pH (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    55. Section 862.1560 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1560 Urinary phenylketones (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    56. Section 862.1570 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1570 Phosphohexose isomerase test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    57. Section 862.1590 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1590 Porphobilinogen test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    58. Section 862.1595 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1595 Porphyrins test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    59. Section 862.1605 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1605 Pregnanediol test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    60. Section 862.1610 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1610 Pregnanetriol test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    61. Section 862.1615 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1615 Pregnenolone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    62. Section 862.1620 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1620 Progesterone test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    63. Section 862.1625 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1625 Prolactin (lactogen) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    64. Section 862.1630 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1630 Protein (fractionation) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    65. Section 862.1645 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1645 Urinary protein or albumin (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    66. Section 862.1650 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1650 Pyruvate kinase test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    67. Section 862.1655 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1655 Pyruvic acid test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    68. Section 862.1660 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1660 Quality control material (assayed and unassayed).

        * * * * *

        (b) Classification. Class I (general controls). Except when used in donor screening tests, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    69. Section 862.1705 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1705 Triglyceride test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    70. Section 862.1725 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1725 Trypsin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

        [[Page 63238]]

    71. Section 862.1780 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1780 Urinary calculi (stones) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    72. Section 862.1785 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1785 Urinary urobilinogen (nonquantitative) test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    73. Section 862.1790 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1790 Uroporphyrin test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    74. Section 862.1795 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1795 Vanilmandelic acid test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    75. Section 862.1805 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1805 Vitamin A test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    76. Section 862.1820 is amended by revising paragraph (b) to read as follows:

        Sec. 862.1820 Xylose test system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    77. Section 862.2140 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2140 Centrifugal chemistry analyzer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    78. Section 862.2150 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    79. Section 862.2160 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2160 Discrete photometric chemistry analyzer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    80. Section 862.2170 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2170 Micro chemistry analyzer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    81. Section 862.2250 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2250 Gas liquid chromatography system for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    82. Section 862.2260 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2260 High pressure liquid chromatography system for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    83. Section 862.2270 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2270 Thin-layer chromatography system for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9. Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    84. Section 862.2300 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    85. Section 862.2400 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    86. Section 862.2500 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2500 Enzyme analyzer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    87. Section 862.2540 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2540 Flame emission photometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    88. Section 862.2560 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2560 Fluorometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    89. Section 862.2680 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2680 Microtitrator for clinical use.

        * * * * *

        [[Page 63239]]

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    90. Section 862.2700 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2700 Nephelometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    91. Section 862.2730 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2730 Osmometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    92. Section 862.2750 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2750 Pipetting and diluting system for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    93. Section 862.2850 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2850 Atomic absorption spectrophotometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    94. Section 862.2860 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2860 Mass spectrometer for clinical use.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    95. Section 862.2900 is amended by revising paragraph (b) to read as follows:

        Sec. 862.2900 Automated urinalysis system.

        * * * * *

        (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    96. Section 862.3280 is amended by revising paragraph (b) to read as follows:

        Sec. 862.3280 Clinical toxicology control material.

        * * * * *

        (b) Classification. Class I (general controls). Except when used in donor screening, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 862.9.

    97. Section 862.3750 is amended by revising paragraph (b) to read as follows:

        Sec. 862.3750 Quinine test system.

        * * * * *

        (b) Classification. Class I.

    98. Section 862.3850 is amended by revising paragraph (b) to read as follows:

        Sec. 862.3850 Sulfonamide test system.

        * * * * *

        (b) Classification. Class I.

        PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    99. The authority citation for 21 CFR part 864 continues to read as follows:

        Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    100. Section 864.9 is revised to read as follows:

         Sec. 864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    101. Section 864.2280 is amended by revising paragraph (b) to read as follows:

         Sec. 864.2280 Cultured animal and human cells.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    102. Section 864.3250 is amended by revising paragraph (b) to read as follows:

         Sec. 864.3250 Specimen transport and storage container.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter

         [[Page 63240]]

         subject to Sec. 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    103. Section 864.5240 is amended by revising paragraph (b) to read as follows:

         Sec. 864.5240 Automated blood cell diluting apparatus.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    104. Section 864.6150 is amended by revising paragraph (b) to read as follows:

         Sec. 864.6150 Capillary blood collection tube.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    105. Section 864.9125 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9125 Vacuum-assisted blood collection system.

         * * * * *

         (b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    106. Section 864.9185 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9185 Blood grouping view box.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    107. Section 864.9195 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9195 Blood mixing devices and blood weighing devices.

         * * * * *

         (b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    108. Section 864.9225 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    109. Section 864.9275 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9275 Blood bank centrifuge for in vitro diagnostic use.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    110. Section 864.9320 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9320 Copper sulfate solution for specific gravity determinations.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

    111. Section 864.9750 is amended by revising paragraph (b) to read as follows:

         Sec. 864.9750 Heat-sealing device.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 864.9.

         PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    112. The authority citation for 21 CFR part 866 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    113. Section 866.9 is revised to read as follows:

         Sec. 866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

         (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    114. Section 866.2660 is amended by revising paragraph (b) to read as follows:

         Sec. 866.2660 Microorganism differentiation and identification device.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the

         [[Page 63241]]

         premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    115. Section 866.3040 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3040 Aspergillus spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    116. Section 866.3140 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3140 Corynebacterium spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    117. Section 866.3145 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3145 Coxsackievirus serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    118. Section 866.3200 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3200 Echinococcus spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    119. Section 866.3240 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3240 Equine encephalomyelitis virus serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    120. Section 866.3355 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3355 Listeria spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    121. Section 866.3360 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3360 Lymphocytic choriomeningitis virus serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    122. Section 866.3375 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3375 Mycoplasma spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    123. Section 866.3380 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3380 Mumps virus serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    124. Section 866.3405 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3405 Poliovirus serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    125. Section 866.3480 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3480 Respiratory syncytial virus serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    126. Section 866.3500 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3500 Rickettsia serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    127. Section 866.3600 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3600 Schistosoma spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    128. Section 866.3680 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3680 Sporothrix schenckii serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    129. Section 866.3740 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3740 Streptococcus spp. serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    130. Section 866.3850 is amended by revising paragraph (b) to read as follows:

         Sec. 866.3850 Trichinella spiralis serological reagents.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    131. Section 866.5060 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5060 Prealbumin immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    132. Section 866.5065 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5065 Human allotypic marker immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    133. Section 866.5160 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5160 Beta-globulin immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    134. Section 866.5200 is amended by revising paragraph (b) to read as follows:

         [[Page 63242]]

         Sec. 866.5200 Carbonic anhydrase B and C immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    135. Section 866.5330 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5330 Factor XIII, A, S, immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9. This exemption does not apply to factor deficiency tests classified under Sec. 864.7290 of this chapter.

    136. Section 866.5400 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5400 Alpha-globulin immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    137. Section 866.5420 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5420 Alpha-1-glycoproteins immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    138. Section 866.5425 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5425 Alpha-2-glycoproteins immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    139. Section 866.5430 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5430 Beta-2-glycoprotein I immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    140. Section 866.5440 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5440 Beta-2-glycoprotein III immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    141. Section 866.5560 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5560 Lactic dehydrogenase immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    142. Section 866.5570 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5570 Lactoferrin immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    143. Section 866.5590 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5590 Lipoprotein X immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    144. Section 866.5715 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5715 Plasminogen immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    145. Section 866.5735 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5735 Prothrombin immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9. This exemption does not apply to multipurpose systems for in vitro coagulation studies classified under Sec. 864.5425 of this chapter or prothrombin time tests classified under Sec. 864.7750 of this chapter.

    146. Section 866.5765 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5765 Retinol-binding protein immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

    147. Section 866.5890 is amended by revising paragraph (b) to read as follows:

         Sec. 866.5890 Inter-alpha trypsin inhibitor immunological test system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 866.9.

         PART 868--ANESTHESIOLOGY DEVICES

    148. The authority citation for 21 CFR part 868 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    149. Section 868.9 is revised to read as follows:

         Sec. 868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific

         [[Page 63243]]

         technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

         (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

    150. Section 868.1910 is amended by revising paragraph (b) to read as follows:

         Sec. 868.1910 Esophageal stethoscope.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 868.9.

    151. Section 868.5620 is amended by revising paragraph (b) to read as follows:

         Sec. 868.5620 Breathing mouthpiece.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 868.9.

    152. Section 868.5640 is amended by revising paragraph (b) to read as follows:

         Sec. 868.5640 Medicinal nonventilatory nebulizer (atomizer).

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 868.9.

    153. Section 868.5675 is amended by revising paragraph (b) to read as follows:

         Sec. 868.5675 Rebreathing device.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 868.9.

    154. Section 868.5700 is amended by revising paragraph (b) to read as follows:

         Sec. 868.5700 Nonpowered oxygen tent.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 868.9.

    155. Section 868.6810 is amended by revising paragraph (b) to read as follows:

         Sec. 868.6810 Tracheobronchial suction catheter.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 868.9.

         PART 870--CARDIOVASCULAR DEVICES

    156. The authority citation for 21 CFR part 870 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    157. Section 870.9 is revised to read as follows:

         Sec. 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

    158. Section 870.4200 is amended by revising paragraph (b) to read as follows:

         [[Page 63244]]

         Sec. 870.4200 Cardiopulmonary bypass accessory equipment.

         * * * * *

         (b) Classification. Class I.

         PART 872--DENTAL DEVICES

    159. The authority citation for 21 CFR part 872 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    160. Section 872.9 is revised to read as follows:

         Sec. 872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

    161. Section 872.3275 is amended by revising paragraph (a)(2) to read as follows:

         Sec. 872.3275 Dental cement.

         (a) * * *

         (2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 872.9. * * * * *

    162. Section 872.3400 is amended by revising paragraph (b)(1) to read as follows:

         Sec. 872.3400 Karaya and sodium borate with or without acacia denture adhesive.

         * * * * *

         (b) Classification. (1) Class I (general controls) if the device contains less than 12 percent by weight of sodium borate. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 872.9. * * * * *

    163. Section 872.3540 is amended by revising paragraph (b)(1) to read as follows:

         Sec. 872.3540 OTC denture cushion or pad.

         * * * * *

         (b) Classification. (1) Class I if the device is made of wax- impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 872.9. * * * * *

    164. Section 872.6300 is amended by revising paragraph (b) to read as follows:

         Sec. 872.6300 Rubber dam and accessories.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    165. Section 872.6390 is amended by revising paragraph (b) to read as follows:

         Sec. 872.6390 Dental floss.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 872.9.

    166. Section 872.6640 is amended by revising paragraph (b) to read as follows:

         Sec. 872.6640 Dental operative unit and accessories.

         * * * * *

         (b) Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 872.9.

         PART 874--EAR, NOSE, AND THROAT DEVICES

    167. The authority citation for 21 CFR part 874 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    168. Section 874.9 is revised to read as follows:

         Sec. 874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within

         [[Page 63245]]

         that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    169. Section 874.1070 is amended by revising paragraph (b) to read as follows:

         Sec. 874.1070 Short increment sensitivity index (SISI) adapter.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    170. Section 874.1100 is amended by revising paragraph (b) to read as follows:

         Sec. 874.1100 Earphone cushion for audiometric testing.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    171. Section 874.1500 is amended by revising paragraph (b) to read as follows:

         Sec. 874.1500 Gustometer.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    172. Section 874.1800 is amended by revising paragraph (b) to read as follows:

         Sec. 874.1800 Air or water caloric stimulator.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    173. Section 874.1925 is amended by revising paragraph (b) to read as follows:

         Sec. 874.1925 Toynbee diagnostic tube.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    174. Section 874.3300 is amended by revising paragraph (b) to read as follows:

         Sec. 874.3300 Hearing Aid.

         * * * * *

         (b) Classification. (1) Class I (general controls) for the air- conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

         (2) Class II for the bone-conduction hearing aid.

    175. Section 874.3540 is amended by revising paragraph (b) to read as follows:

         Sec. 874.3540 Prosthesis modification instrument for ossicular replacement surgery.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    176. Section 874.4100 is amended by revising paragraph (b) to read as follows:

         Sec. 874.4100 Epistaxis balloon.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    177. Section 874.4420 is amended by revising paragraph (b) to read as follows:

         Sec. 874.4420 Ear, nose, and throat manual surgical instrument.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    178. Section 874.5300 is amended by revising paragraph (b) to read as follows:

         Sec. 874.5300 Ear, nose, and throat examination and treatment unit.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    179. Section 874.5550 is amended by revising paragraph (b) to read as follows:

         Sec. 874.5550 Powered nasal irrigator.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the

         [[Page 63246]]

         premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

    180. Section 874.5840 is amended by revising paragraph (b) to read as follows:

         Sec. 874.5840 Antistammering device.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.

         PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

    181. The authority citation for 21 CFR part 876 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    182. Section 876.9 is revised to read as follows:

         Sec. 876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

    183. Section 876.5160 is amended by revising paragraph (b) to read as follows:

         Sec. 876.5160 Urological clamp for males.

         * * * * *

         (b) Classification. Class I (general controls). Except when intended for internal use or use on females, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 876.9.

    184. Section 876.5210 is amended by revising paragraph (b) to read as follows:

         Sec. 876.5210 Enema kit.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 876.9. The device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    185. Section 876.5250 is amended by revising paragraph (b)(2) to read as follows:

         Sec. 876.5250 Urine collector and accessories.

         * * * * *

         (b) * * *

         (2) Class I (general controls) for a urine collector and accessories not intended to be connected to an indwelling catheter. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to the general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    186. Section 876.5980 is amended by revising paragraph (b)(2) to read as follows:

         Sec. 876.5980 Gastrointestinal tube and accessories.

         * * * * *

         (b) * * *

         (2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 876.9.

         PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    187. The authority citation for 21 CFR part 878 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    188. Section 878.9 is revised to read as follows:

         Sec. 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or

         [[Page 63247]]

         effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

    189. Section 878.3250 is amended by revising paragraph (b) to read as follows:

         Sec. 878.3250 External facial fracture fixation appliance.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    190. Section 878.3910 is amended by revising paragraph (b) to read as follows:

         Sec. 878.3910 Noninflatable extremity splint.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    191. Section 878.3925 is amended by revising paragraph (b) to read as follows:

         Sec. 878.3925 Plastic surgery kit and accessories.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    192. Section 878.4040 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4040 Surgical apparel.

         * * * * *

         (b) Classification. (1) Class II (special controls) for surgical gowns and surgical masks.

         (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    193. Section 878.4100 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4100 Organ bag.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    194. Section 878.4200 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4200 Introduction/drainage catheter and accessories.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    195. Section 878.4320 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4320 Removable skin clip.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    196. Section 878.4680 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4680 Nonpowered, single patient, portable suction apparatus.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    197. Section 878.4760 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4760 Removable skin staple.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    198. Section 878.4820 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4820 Surgical instrument motors and accessories/attachments.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

    199. Section 878.4960 is amended by revising paragraph (b) to read as follows:

         Sec. 878.4960 Operating tables and accessories and operating chairs and accessories.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 878.9.

         PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    200. The authority citation for 21 CFR part 880 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    201. Section 880.9 is revised to read as follows:

         [[Page 63248]]

         Sec. 880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

         (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

    202. Section 880.5090 is amended by revising paragraph (b) to read as follows:

         Sec. 880.5090 Liquid bandage.

         * * * * *

         (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 880.9.

    203. Section 880.5270 is amended by revising paragraph (b) to read as follows:

         Sec. 880.5270 Neonatal eye pad.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    204. Section 880.5420 is amended by revising paragraph (b) to read as follows:

         Sec. 880.5420 Pressure infusor for an I.V. bag.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 880.9.

         PART 882--NEUROLOGICAL DEVICES

    205. The authority citation for 21 CFR part 882 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    206. Section 882.9 is revised to read as follows:

         Sec. 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         [[Page 63249]]

         (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

         (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    207. Section 882.1200 is amended by revising paragraph (b) to read as follows:

         Sec. 882.1200 Two-point discriminator.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    208. Section 882.1500 is amended by revising paragraph (b) to read as follows:

         Sec. 882.1500 Esthesiometer.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    209. Section 882.1750 is amended by revising paragraph (b) to read as follows:

         Sec. 882.1750 Pinwheel.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9.

    210. Section 882.4060 is amended by revising paragraph (b) to read as follows:

         Sec. 882.4060 Ventricular cannula.

         * * * * *

         (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9.

    211. Section 882.4545 is amended by revising paragraph (b) to read as follows:

         Sec. 882.4545 Shunt system implantation instrument.

         * * * * *

         (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9.

    212. Section 882.4650 is amended by revising paragraph (b) to read as follows:

         Sec. 882.4650 Neurosurgical suture needle.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9.

    213. Section 882.4750 is amended by revising paragraph (b) to read as follows:

         Sec. 882.4750 Skull punch.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 882.9. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under Sec. 882.4305.

         PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    214. The authority citation for 21 CFR part 884 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    215. Section 884.9 is revised to read as follows:

         Sec. 884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    216. Section 884.1040 is amended by revising paragraph (b) to read as follows:

         Sec. 884.1040 Viscometer for cervical mucus.

         * * * * *

         [[Page 63250]]

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 884.9.

         PART 886--OPHTHALMIC DEVICES

    217. The authority citation for 21 CFR part 886 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    218. Section 886.9 is revised to read as follows:

         Sec. 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    219. Section 886.1780 is amended by revising paragraph (b) to read as follows:

         Sec. 886.1780 Retinoscope.

         * * * * *

         (b) Classification. (1) Class II (special controls) for the AC- powered device.

         (2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 886.9. The battery-powered device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    220. Section 886.1940 is amended by revising paragraph (b) to read as follows:

         Sec. 886.1940 Tonometer sterilizer.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 886.9.

    221. Section 886.4070 is amended by revising paragraph (b) to read as follows:

         Sec. 886.4070 Powered corneal burr.

         * * * * *

         (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 886.9.

    222. Section 886.4300 is amended by revising paragraph (b) to read as follows:

         Sec. 886.4300 Intraocular lens guide.

         * * * * *

         (b) Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 886.9.

    223. Section 886.4750 is amended by revising paragraph (b) to read as follows:

         Sec. 886.4750 Ophthalmic eye shield.

         * * * * *

         (b) Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    224. Section 886.5850 is amended by revising paragraph (b) to read as follows:

         Sec. 886.5850 Sunglasses (nonprescription).

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 886.9.

         PART 888--ORTHOPEDIC DEVICES

    225. The authority citation for 21 CFR part 888 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    226. Section 888.9 is revised to read as follows:

         Sec. 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the

         [[Page 63251]]

         device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and (9) For near patient testing (point of care).

         PART 890--PHYSICAL MEDICINE DEVICES

    227. The authority citation for 21 CFR part 890 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    228. Section 890.9 is revised to read as follows:

         Sec. 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

         (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management;

         (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

         (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    229. Section 890.1175 is amended by revising paragraph (b) to read as follows:

         Sec. 890.1175 Electrode cable.

         * * * * *

         (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 890.9. The devices are exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files.

    230. Section 890.5180 is amended by revising paragraph (b) to read as follows:

         Sec. 890.5180 Manual patient rotation bed.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 890.9.

    231. Section 890.5710 is amended by revising paragraph (b) to read as follows:

         Sec. 890.5710 Hot or cold disposable pack.

         * * * * *

         (b) Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 890.9.

         [[Page 63252]]

         PART 892--RADIOLOGY DEVICES

    232. The authority citation for 21 CFR part 892 continues to read as follows:

         Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    233. Section 892.9 is revised to read as follows:

         Sec. 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

         The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, for which a misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

         (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

         (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

         (c) The device is an in vitro device that is intended:

         (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism;

         (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

         (4) For assessing the risk of cardiovascular diseases;

         (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material;

         (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) and IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

         (8) For noninvasive testing as defined in Sec. 812.3(k) of this chapter; and

         (9) For near patient testing (point of care).

    234. Section 892.1300 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1300 Nuclear rectilinear scanner.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    235. Section 892.1320 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1320 Nuclear uptake probe.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    236. Section 892.1330 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1330 Nuclear whole body scanner.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    237. Section 892.1350 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1350 Nuclear scanning bed.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    238. Section 892.1410 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1410 Nuclear electrocardiograph synchronizer.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    239. Section 892.1890 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1890 Radiographic film illuminator.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    240. Section 892.1910 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1910 Radiographic grid.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    241. Section 892.1960 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1960 Radiographic intensifying screen.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    242. Section 892.1970 is amended by revising paragraph (b) to read as follows:

         Sec. 892.1970 Radiographic ECG/respirator synchronizer.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    243. Section 892.2010 is amended by revising paragraph (b) to read as follows:

         Sec. 892.2010 Medical image storage device.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    244. Section 892.2020 is amended by revising paragraph (b) to read as follows:

         Sec. 892.2020 Medical image communications device.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    245. Section 892.5650 is amended by revising paragraph (b) to read as follows:

         [[Page 63253]]

         Sec. 892.5650 Manual radionuclide applicator system.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

    246. Section 892.6500 is amended by revising paragraph (b) to read as follows:

         Sec. 892.6500 Personnel protective shield.

         * * * * *

         (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 892.9.

         Dated: October 14, 1998. William B. Schultz, Deputy Commissioner for Policy.

         [FR Doc. 98-29855Filed11-10-98; 8:45 am]

         BILLING CODE 4160-01-F