E6-21901. Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Procedures for Handling Post-Approval Studies Imposed by PMA Order.” The guidance provides a standard format and content for submitting post-approval studies. The guidance is issued to help ensure that sponsors provide adequate information about the conduct of post-approval studies and that the Center for Devices and Radiological Health (CDRH) can properly track and evaluate post-approval studies.

DATES:

Submit written or electronic 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 “Procedures for Handling Post-Approval Studies Imposed by PMA Order” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this guidance 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.fda.gov/​dockets/​ecomments. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Steven H. Chasin, Center for Devices and Radiological Health (HFZ- 520), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3421.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance provides recommendations to sponsors and CDRH staff on expectations concerning format, content, and review of reports related to post-approval studies imposed by premarket approval application order to help ensure that the studies are conducted effectively and efficiently, and in a least burdensome manner. The guidance has been drafted in response to concerns by Congress, the Institute of Medicine, and FDA about the agency's ability to monitor and track these studies and industry's requests for more clarity about the agency's expectations. FDA received a few comments on the draft document (announced at 70 FR 54561, September 15, 2005) and has made minor changes to the guidance.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on post-approval 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 guidance may do so by using the Internet. To receive “Procedures for Handling Post-Approval Studies Imposed by PMA Order,” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number (1561) to identify the guidance you are requesting.

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/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA's 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 814 have been approved under OMB Control No. 0910-0231; the collections of information in 21 CFR part 822 have been approved under OMB Control No. 0910-0449.

V. Comments

Interested persons may submit to the Division of Dockets Management (See ADDRESSES), written or electronic comments regarding this document at any time. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Submit two paper 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. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: December 13, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.