[Federal Register: November 3, 2003 (Volume 68, Number 212)]
[Page 62298-62299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1998D-0896]

Guidance for Industry and Food and Drug Administration Staff; 
Premarket Approval Application Modular Review; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Premarket Approval 
Application Modular Review.'' This guidance document is intended to 
provide industry and FDA staff with information regarding the premarket 
approval application (PMA) modular review program. This guidance 
document is immediately in effect, but it remains subject to comment in 
accordance with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on agency guidances at any 

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Premarket Approval 
Application Modular Review'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health (CDRH), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Nicole Wolanski, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.


I. Background

    This guidance document provides FDA's recommendations about the 
content of a modular PMA and the procedures for submitting and 
reviewing a modular PMA. This document supersedes and replaces the 
guidance document entitled ``Guidance for the Medical Device Industry 
on PMA Shell Development and Modular Review'' issued on November 6, 
    FDA is making this guidance effective immediately because there is 
a statutory requirement that requires immediate implementation, and 
guidance is needed to help effect such implementation. On October 26, 
2002, the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA) was signed into law. Section 209 of MDUFMA amended section 
515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), 
to codify FDA's modular review program for PMAs and authorize FDA to 
assess user fees for modular PMAs. In developing this guidance, the 
agency has considered its experience with its modular review program 
and comments on the topic that were submitted to the public docket on 
MDUFMA Implementation (Docket No. 02N-0534 (68 FR 5643, February 4, 

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on modular PMAs. 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing PMAs (21 CFR part 814, OMB control number 0910-0231).

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments on the guidance at any 
time. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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. The guidance and comments received may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    To receive a copy of ``Premarket Approval Application Modular 
Review'' by fax, call the CDRH Facts-On-Demand system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt, press 1 to order a document. Enter 
the document number (835) followed by the pound sign ([numsign]). 
Follow the remaining voice prompts to complete your request.

[[Page 62299]]

    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.

Guidance documents are also available on the Division of Dockets 
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

    Dated: October 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27561 Filed 10-31-03; 8:45 am]