E8-126. Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.” This guidance document explains for premarket approval application (PMA) applicants the process involved with the review of a PMA manufacturing section and inspection of the manufacturing operations described in the manufacturing section. This guidance is also generally applicable to the process involved with the review of manufacturing information in certain PMA supplements. The procedural information outlined in this document should help applicants and FDA schedule and complete their work in a timely manner.

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 “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations” 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 or http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Timothy A. Ulatowski, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-0100.

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, MDUFMA (Public Law 107-250), amended the Federal Food, Drug, and Cosmetic Act (the act). Among other things, MDUMFA authorized the collection of user fees to improve the performance and predictability of FDA's device premarket review process, which includes PMAs. FDA, in consultation with the regulated industry, agreed to dedicate user fees to help the agency achieve performance goals, including the predictability of scheduling and timeliness of preapproval inspections.

This final guidance document, “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” explains for PMA applicants the administrative process FDA intends to follow in its review of the PMA manufacturing section information and the inspection of the particular manufacturing facility and its manufacturing operations. This final guidance document supersedes the corresponding draft guidance issued on June 19, 2006 (71 FR 35275 through 35276).

The comment period for the draft guidance document closed on September 18, 2006. During the comment period, we received several comments and recommendations. Two comments recommended that the agency inspect pilot manufacturing operations or the manufacture of a surrogate product in lieu of inspecting the complete manufacturing operation described in the PMA manufacturing section. FDA disagrees with this recommendation as the statute does not provide such an alternative. The statute requires the agency to determine whether the manufacturing operations, as described in the PMA, conform to good manufacturing practice requirements.

Several comments recommended clarification of certain terms related to the process involved with scheduling inspections and factors that affect the PMA manufacturing section review process. The agency incorporated many of the suggested clarifications.

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 “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.” 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 “The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations,” 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 1566 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 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 USC 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB Control Number 0910-0231; and the collections of information in 21 CFR part 820 have been approved under OMB Control Number 0910-0073.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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: December 20, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.