Draft Guidance for Industry and Food and Drug Administration Staff: Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability
Federal Register: April 5, 2010 (Volume 75, Number 64)
Notices
Page 17143-17145
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr05ap10-61
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2009-D-0495
Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices; Neurological and Physical Medicine Device
Guidance Documents; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft special controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls guidance document for each of the 11 devices. These draft guidance documents describe a means by which these devices may comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate special controls for each of these devices and would exempt six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the act).
These draft guidance documents are not final nor are they in effect at this time.
DATES: Although you can comment on any guidance documents at any time
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(see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on any of these draft guidances before it begins work on the final versions of the guidances, submit written or electronic comments by July 6, 2010.
ADDRESSES: Submit written requests for single copies of any or all of the draft guidance documents to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4617, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the draft guidance documents.
Submit written comments concerning any of the draft guidance documents to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Robert J. DeLuca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002, e- mail: Robert.DeLuca@fda.hhs.gov, 301-796-6630.
SUPPLEMENTARY INFORMATION:
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Background
FDA is announcing the availability of the following 11 draft guidance documents:
(1) ``Class II Special Controls Guidance Document:
Electroconductive Media; Draft Guidance for Industry and FDA Staff'';
(2) ``Class II Special Controls Guidance Document: Cutaneous
Electrode; Draft Guidance for Industry and FDA Staff'';
(3) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Nerve Stimulator for Pain Relief; Draft Guidance for
Industry and FDA Staff'';
(4) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Nerve Stimulator for Pain Relief Intended for Over the
Counter Use; Draft Guidance for Industry and FDA Staff'';
(5) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Nerve Stimulator with Limited Output for Pain Relief; Draft
Guidance for Industry and FDA Staff'';
(6) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Stimulator for Aesthetic Purposes; Draft Guidance for
Industry and FDA Staff'';
(7) ``Class II Special Controls Guidance Document: Transcutaneous
Electrical Stimulator with Limited Output for Aesthetic Purposes; Draft
Guidance for Industry and FDA Staff'';
(8) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator for Rehabilitation; Draft Guidance for Industry and FDA
Staff'';
(9) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator with Limited Output for Rehabilitation; Draft Guidance for
Industry and FDA Staff'';
(10) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator for Muscle Conditioning; Draft Guidance for Industry and FDA
Staff''; and
(11) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator with Limited Output for Muscle Conditioning; Draft Guidance for Industry and FDA Staff.''
Each draft special controls guidance document identifies the classification, product code, and classification identification for each of the respective 11 device types. In addition, they would serve as special controls that, when followed and combined with the general controls and any other applicable special controls, would generally address the risks associated with these devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate special controls for these devices. The rule also proposes to exempt the following six device types from premarket notification requirements if they follow the designated special controls, including addressing the issues identified in the special controls guidance documents by following the guidances' recommendations: (1) Electroconductive media; (2) cutaneous electrode;
(3) transcutaneous electrical nerve stimulator with limited output for pain relief; (4) transcutaneous electrical stimulator with limited output for aesthetic purposes; (5) powered muscle stimulator with limited output for rehabilitation; and (6) powered muscle stimulator with limited output for muscle conditioning.
These draft guidance documents were developed to describe a means by which these devices may comply with the requirement of special controls for class II devices. FDA believes that special controls, when combined with the general controls, would be sufficient to provide reasonable assurance of the safety and effectiveness of these devices.
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Significance of Guidance
These draft guidance documents are being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized will reflect the agency's current thinking regarding (1) Electroconductive media; (2) the cutaneous electrode; (3) the transcutaneous electrical nerve stimulator for pain relief; (4) the transcutaneous electrical nerve stimulator for pain relief intended for over the counter use; (5) the transcutaneous electrical nerve stimulator with limited output for pain relief; (6) the transcutaneous electrical stimulator for aesthetic purposes; (7) the transcutaneous electrical stimulator with limited output for aesthetic purposes; (8) the powered muscle stimulator for rehabilitation; (9) the powered muscle stimulator with limited output for rehabilitation; (10) the powered muscle stimulator for muscle conditioning; and (11) the powered muscle stimulator with limited output for muscle conditioning. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both.
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Electronic Access
To receive any or all of the following 11 draft guidance documents you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document(s) or send a fax request to 301-847- 8149 to receive a hard copy. Please use the document number to identify the guidance you are requesting: (1) ``Class II Special Controls
Guidance Document: Electroconductive Media; Draft Guidance for Industry and FDA Staff'' (1571); (2) ``Class II Special Controls Guidance
Document: Cutaneous Electrode; Draft Guidance for Industry and FDA
Staff'' (1572); (3) ``Class II Special Controls Guidance Document:
Transcutaneous Electrical Nerve Stimulator for Pain Relief; Draft
Guidance for Industry and FDA Staff'' (1573); (4) ``Class II Special
Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use; Draft Guidance for
Industry and FDA Staff'' (1670); (5) ``Class II Special Controls
Guidance Document:
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Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain
Relief; Draft Guidance for Industry and FDA Staff'' (1574); (6) ``Class
II Special Controls Guidance Document: Transcutaneous Electrical
Stimulator for Aesthetic Purposes; Draft Guidance for Industry and FDA
Staff'' (1575); (7) ``Class II Special Controls Guidance Document:
Transcutaneous Electrical Stimulator with Limited Output for Aesthetic
Purposes; Draft Guidance for Industry and FDA Staff'' (1576); (8)
``Class II Special Controls Guidance Document: Powered Muscle
Stimulator for Rehabilitation; Draft Guidance for Industry and FDA
Staff'' (1577); (9) ``Class II Special Controls Guidance Document:
Powered Muscle Stimulator with Limited Output for Rehabilitation; Draft
Guidance for Industry and FDA Staff'' (1578); (10) ``Class II Special
Controls Guidance Document: Powered Muscle Stimulator for Muscle
Conditioning; Draft Guidance for Industry and FDA Staff'' (1579); and/ or (11) ``Class II Special Controls Guidance Document: Powered Muscle
Stimulator with Limited Output for Muscle Conditioning; Draft Guidance for Industry and FDA Staff'' (1580).
Persons interested in obtaining a copy of any or all of the draft guidance documents may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with
Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/MedicalDevices/default.htm. A search capability for all CDRH guidance documents is available at http:// www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov.
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Paperwork Reduction Act of 1995
These 11 draft guidance documents refer to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in part 807 (21 CFR part 807), subpart E pertain to premarket submission requirements for any person who intends to market certain medical devices, and have been approved under OMB control number 0910-0120.
Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule that would designate special controls for each of these devices and would exempt six of them from the premarket notification requirements of the act. The proposed rule contains an analysis of the paperwork burden for the proposed rule, including the anticipated reduction in burden for manufacturers who follow the special controls and for manufacturers of the six proposed exempt device types.
Consistent with the Paperwork Reduction Act of 1995, we solicit comment on our revised burden estimates.
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Comments
The agency is specifically interested in comments on the types of claims appropriate for devices included within these 11 classifications and, for the devices that remain subject to premarket review, the data sponsors should submit to support those claims. For example, under the proposed rule, certain transcutaneous electrical stimulators for aesthetic purposes would remain subject to 510(k). The agency is interested in comments on the type of data sponsors should submit to show a transcutaneous electrical nerve stimulator device achieves
``aesthetic effects through physical change to the structure of the body'' as well as the predicate device does.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two copies of any mailed comments, except that individuals may submit one copy.
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
Division of Dockets between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 24, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
FR Doc. 2010-7634 Filed 4-2-10; 8:45 am
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