Medical devices: Vitamin D test system; reclassification and codification,

[Federal Register: July 29, 1998 (Volume 63, Number 145)]

[Rules and Regulations]

[Page 40364-40366]

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

[DOCID:fr29jy98-5]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 96P-0228]

Medical Devices; Reclassification and Codification of Vitamin D Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to INCSTAR Corp. reclassifying INCSTAR 25-Hydroxyvitamin D ‹SUP›125‹/SUP›I Radioimmunoassay (RIA). This radioimmunoassay device is intended for use in clinical laboratories for the quantitative determination of 25- hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency. The device and substantially equivalent devices of this generic type were reclassified from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations.

EFFECTIVE DATES: The regulation is effective August 28, 1998. The reclassification was effective September 24, 1996.

FOR FURTHER INFORMATION CONTACT: Sharon K. Lappalainen, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

1. Background (Regulatory Authorities)

   The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation

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   classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures. Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: (1) The device is reclassified into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with new section 513(f)(2) of the act as amended by FDAMA; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations. A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application (PMA) until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval. Reclassification of postamendments devices is governed by section 513(f)(3) of the act, formerly section 513(f)(2) of the act. This section provides that FDA may initiate the reclassification of a device classified into class III under section 513(f)(1) of the act, or the manufacturer or importer of a device may petition the Secretary of the Department of Health and Human Services (the Secretary) for the issuance of an order classifying the device in class I or class II. FDA's regulations in Sec. 860.134 (21 CFR 860.134) set forth the procedures for the filing and review of a petition for reclassification of such class III devices. In order to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. FDAMA added paragraph (f)(2) in section 513 of the act that addresses classification of postamendments devices. New paragraph (f)(2) in section 513 of the act provides that upon receipt of a ``not substantially equivalent'' determination, a 510(k) applicant may request FDA to classify a postamendments device into class I or class II. Within 60 days from the date of such a written request, FDA must classify the device by written order. If FDA classifies the device into class I or II, the applicant has then received clearance to market the device and it can be used as a predicate device for other 510(k)'s. It is expected that this will be used for low risk devices. This process does not apply to devices that have been classified by regulation into class III--i.e., preamendments class III devices, or class III devices for which a PMA is appropriate. Under section 513(f)(3)(B)(i) of the act, formerly section 513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown, refer a petition to a device classification panel. If a petition is referred to a panel, the panel shall make a recommendation to the Secretary respecting approval or denial of the petition. Any such recommendation shall contain: (1) A summary of the reasons for the recommendation, (2) a summary of the data upon which the recommendation is based, and (3) an identification of the risks to health (if any) presented by the device with respect to which the petition was filed. On July 1, 1996, FDA filedthe reclassification petition submitted by INCSTAR Corp., requesting reclassification of the vitamin D test system from class III to class II. On the basis of FDA's review of the data submitted in the reclassification petition, and after reviewing the panel's recommendations on two previous petitions submitted in 1983 and 1985 regarding the quantitative measurement of vitamin D, FDA issued an order to the petitioner, reclassifying vitamin D test system for use in clinical laboratories for the quantitative determination of 25-OH-D and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency, and substantially equivalent devices of this generic type, from class III to class II. Accordingly, as required by Sec. 860.134(b)(7) of the regulations, FDA is announcing the reclassification of the vitamin D test system intended for use in clinical laboratories for the quantitative determination of 25-OH-D and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency from class III into class II. In addition, FDA is issuing the notice to codify the reclassification of the device by adding new Sec. 862.1825.

2. Environmental Impact

   The agency has determined under 21 CFR 25.34(b) that this reclassification is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

3. Analysis of Impacts

   FDA has examined the impacts of this final rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354) (as amended by the 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 final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final 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 agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of this device from class III to class II will relieve all manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace by lowering their costs. The agency therefore certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In addition, this final rule will not impose costs of $100 million or more on either the private sector or state, local, and tribal governments in the aggregate, and therefore a summary statement or analysis under section 202(a) of the Unfunded Mandates Refund Act of 1995 is not required.

4. Paperwork Reduction Act of 1995

   FDA has determined that this final 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.

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   List of Subjects in 21 CFR Part 862

   Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended 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 862.1825 is added to subpart B to read as follows:

      Sec. 862.1825 Vitamin D test system.

      (a) Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency. (b) Classification. Class II (special controls).

      Vitamin D test systems must comply with the following special controls: (1) Labeling in conformance with 21 CFR 809.10 and (2) compliance with existing standards of the National Committee on Clinical Laboratory Standards.

      Dated: July 17, 1998. D.B. Burlington. Director, Center for Devices and Radiological Health.

      [FR Doc. 98-20241Filed7-28-98; 8:45 am]

      BILLING CODE 4160-01-F