[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44594-44595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18805]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0465]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Repetitive Transcranial
Magnetic Stimulation Systems; 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 the guidance entitled ``Class II Special Controls
Guidance Document: Repetitive Transcranial Magnetic Stimulation
Systems.'' This guidance document describes a means by which a
repetitive transcranial magnetic stimulation (rTMS) system may comply
with the requirement of special controls for class II devices. This
guidance document is being immediately implemented as the special
control for rTMS systems, but it remains subject to comment in
accordance with the Agency's good guidance practices.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Repetitive Transcranial Magnetic Stimulation Systems'' 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. 4613, 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 guidance.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ann H. Costello, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2460, Silver Spring, MD 20993-0002, 301-
796-6493.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document will serve as the special control for rTMS
systems. Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360c(f)(2)) provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) for a device that has not previously been classified
may, within 30 days after receiving an order classifying the device in
class III under section 513(f)(1) of the FD&C Act, request FDA to
classify the device under the criteria set forth in section 513(a)(1)
of the FD&C Act. FDA will, within 60 days of receiving such a request,
classify the device by written order. This classification will be the
initial classification of the device. Within 30 days after the issuance
of an order classifying the device, FDA must publish a notice in the
Federal Register announcing this classification. Because of the
timeframes established by section 513(f)(2) of the FD&C Act, FDA has
determined, under 21 CFR 10.115(g)(2), that it is not feasible to allow
for public participation before issuing this guidance as a final
guidance document. Thus, FDA is issuing this guidance document as a
level 1 guidance document that is for immediate implementation. FDA
will consider any comments that are received in response to this notice
to determine whether to revise the guidance document. Elsewhere in this
issue of the Federal Register, FDA is publishing a final rule
classifying rTMS systems into class II (special controls), under
section 513(f)(2) of the FD&C Act.
II. Significance of Special Controls Guidance
FDA believes that adherence to the recommendations described in
this guidance, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of rTMS systems
classified under 882.5805 (21 CFR 882.5805). In order to be classified
as a class II device under 882.5805, a rTMS system must comply with the
requirements of special controls; manufacturers must address the issues
requiring special controls as identified in the guidance document,
either by following the recommendations in the guidance document or by
some other means that provides equivalent assurances of safety and
effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. 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.
To receive ``Class II Special Controls Guidance Document:
Repetitive Transcranial Magnetic Stimulation (rTMS) Systems'' you may
either send an e-mail request to [email protected] to receive an
electronic copy of the document or send a fax request to 301-847-8149
to receive a paper copy. Please use the document number 1728 to
identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers 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 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR 56.115 have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 44595]]
Dated: July 20, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18805 Filed 7-25-11; 8:45 am]
BILLING CODE 4160-01-P