[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Notices]
[Pages 17143-17145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7634]
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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Draft Guidance for Industry and Food and Drug Administration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draft guidance documents describe a means by which these devices may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These draft guidance documents are not final nor are they in effect at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the draft guidance documents to the Division of Small Manufacturers,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INFORMATION section for information on electronic access to the draft
guidance documents.
Submit written comments concerning any of the draft guidance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: [email protected], 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 [email protected] 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]
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