[Federal Register Volume 73, Number 5 (Tuesday, January 8, 2008)]
[Notices]
[Pages 1358-1359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-126]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0063]


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.

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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.

[[Page 1359]]

    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 [email protected] 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.
[FR Doc. E8-126 Filed 1-7-08; 8:45 am]
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