[Federal Register: November 26, 2003 (Volume 68, Number 228)]
[Page 66463-66464]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1998D-0173]

Guidance for Industry and FDA Staff: Expedited Review of
Premarket Submissions for Devices; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Expedited Review of Premarket
Submissions for Devices.'' This guidance describes how the agency is
applying the statutory criteria and the additional criteria identified
in a letter accompanying the user fee legislation to meet the new
performance goals for expedited premarket approval applications (PMAs).
This guidance also describes FDA's expedited review procedures for
premarket notification submissions (510(k)s), product development
protocols (PDPs), and de novo classification actions. 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 this guidance at any
time. General comments on agency guidance documents are welcome at any

ADDRESSES:  Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Expedited Review of
Premarket Submissions for Devices'' 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 two 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 questions regarding PMAs: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD
20850, 301-594-2186.
    For questions regarding 510(k)s, including the evaluation of
automatic class III designation: Heather Rosecrans, Center for Devices
and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD
20850, 301-594-1190.
    For questions regarding devices regulated by the Center for
Biologics Evaluation and Research: Sayah Nedjar, Center for Biologics
Evaluation and Research (HFM-380), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-3524.


I. Background

    In the Federal Register of March 31, 1998 (63 FR 15427), FDA issued
a guidance entitled ``PMA/510(k) Expedited Review Guidance for Industry
and the Center for Devices and Radiological Health (CDRH) Staff'' in
which the agency outlined its interpretation of the statutory criteria
for expedited review of PMAs. No comments were received on the
    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250), was signed into law on October 26, 2002.
Performance goals for expedited PMAs were referenced in the statute and
apply to such applications when newly identified criteria are met by
the applicant (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma/pgoals.html). The new
guidance entitled ``Expedited Review of Premarket Submissions for
Devices'' supersedes and replaces the 1998 guidance document and
explains the procedures that FDA intends to use to review and track
expedited PMA applications against the MDUFMA performance goals when
the PMA applicant meets the additional criteria. The new guidance also
explains the procedures that FDA plans to use to expedite the review of
PDPs, 510(k)s, and de novo classification actions.
    Because the agency had to implement its program for meeting the
expedited review performance goals as soon as the new law became
effective. FDA has determined, under Sec. 10.115(g)(2) (21 CFR
10.115(g)(2)), that it was not feasible to obtain comments before
issuing this guidance. Therefore, in accordance with FDA's GGP
procedures, FDA is issuing this as a level 1 guidance that is
immediately in effect and will accept comments on the guidance at any

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
agency's current thinking on procedures for expedited review of PMAs,
given the enhanced PMA performance goals for expedited applications.
The guidance also discusses the expedited review procedures for
510(k)s, PDPs, and de novo classification actions. 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 statutes and regulations.

III. Electronic Access

    To receive ``Expedited Review of Premarket Submissions for
Devices'' by fax machine, 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 (108) followed by the pound sign ().
Follow the remaining voice prompts to complete your request.
    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.

[[Page 66464]]

 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.

IV. 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 (44 U.S.C. 3501-3520) (the PRA).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
for premarket approval applications (21 CFR part 814, OMB control
number 0910-0231) and the regulations for premarket notification
submissions (21 CFR part 807, OMB control number 0910-0120).

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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
 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: November 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29463 Filed 11-25-03; 8:45 am]