Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Procedures for Handling Section 522 Postmarket Surveillance Studies.”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 This draft guidance is not final nor is it in effect at this time.

Table of Contents

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 14, 2011.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Submit written requests for single copies of the draft guidance document entitled “Procedures for Handling Section 522 Postmarket Surveillance Studies” to the Division of Small Manufacturers, International, and Consumer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Submit electronic comments on the draft guidance to http://www.regulations.gov.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&CAct 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 dsmica@fda.hhs.gov 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.

References

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