Document ID: FDA-2009-D-0495-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability
Posted Date: 2010-04-05T04:00Z

[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]                         

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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Draft Guidance for Industry and Food and Drug Administration 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.

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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draft guidance documents describe a means by which these devices may 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These draft guidance documents are not final nor are they in effect at 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

[[Page 17144]]

(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the draft guidance documents to the Division of Small Manufacturers, 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:

I. 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.

II. 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.

III. 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:

[[Page 17145]]

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.

IV. 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.

V. 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]
BILLING CODE 4160-01-S