Document ID: FDA-2011-D-0465-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff; Availability: Class II Special Controls; Repetitive Transcranial Magnetic Stimulation Systems
Posted Date: 2011-07-26T04:00Z

[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44594-44595]
From the Federal Register Online via the Government Printing 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 dsmica@fda.hhs.gov 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