[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50740-50741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20727]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0514]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Procedures for Handling Section 522 Postmarket Surveillance 
Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Procedures for Handling 
Section 522 Postmarket Surveillance Studies.'' This guidance document 
is intended to assist device manufacturers subject to a section 522 
postmarket surveillance order imposed by FDA by providing an overview 
of section 522 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), procedural information on how to fulfill section 522 obligations, 
and recommendations on the format, content, and review of postmarket 
surveillance study submissions. This draft guidance is not final nor is 
it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Procedures for Handling Section 522 
Postmarket Surveillance Studies'' 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Mary Beth Ritchey, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4115, Silver Spring, MD 20993-0002, 301- 
96-6638.

SUPPLEMENTARY INFORMATION:

I. Background

    Postmarket surveillance under section 522 of the FD&C Act (21 
U.S.C. 306l) is one means by which FDA can obtain additional 
information when it is necessary to protect the public health or 
provide safety and/or effectiveness data for a device after it has been 
cleared or approved. The Food and Drug Administration Amendments Act of 
2007 amended section 522 of the FD&C

[[Page 50741]]

Act to expand the situations in which FDA may order postmarket 
surveillance and allow longer surveillance periods in certain 
circumstances. This guidance document is intended to assist device 
manufacturers subject to a section 522 postmarket surveillance order by 
providing an overview of section 522 of the FD&C Act, procedural 
information on how to fulfill section 522 obligations, and 
recommendations on the format, content, and review of postmarket 
surveillance study submissions.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on ``Procedures 
for Handling Section 522 Postmarket Surveillance Studies.'' It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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 
``Procedures for Handling Section 522 Postmarket Surveillance Studies'' 
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 hard copy. Please use the document number 1754 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 822 have been approved under 
OMB control number 0910-0449.

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.

    Dated: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20727 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P