[Federal Register: May 21, 2004 (Volume 69, Number 99)]
[Notices]               
[Page 29314-29315]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my04-97]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0538]

 
Guidance for Industry and Food and Drug Administration Staff: 
Food and Drug Administration and Industry Actions on Premarket 
Notification Submissions: Effect on Food and Drug Administration Review 
Clock and Performance Assessment; 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 ``FDA and Industry Actions on 
Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock 
and Performance Assessment.'' This guidance describes how FDA will 
assess its performance in the premarket notification (510(k)) program 
relative to the goals that accompany the authorization of medical 
device user fees. 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.

ADDRESSES: Submit written requests for single copies on a 
3.5 diskette of the guidance document entitled ``FDA and 
Industry Actions on Premarket Notification (510(k)) Submissions: Effect 
on FDA Review Clock and Performance Assessment'' 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 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 FURTHER INFORMATION CONTACT: 
    For device issues: Heather Rosecrans, Center for Devices and 
Radiological Health (HFZ-404), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1190, ext. 143.
    For biologics issues: Leonard Wilson, Center for Biologics 
Evaluation and Research (CBER) (HFM-25), Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Public Law 107-250), signed into law on October 26, 2002, allows FDA 
to assess user fees for certain premarket reviews. Performance goals, 
referenced in the statute, accompany the authorization of medical 
device user fees. These goals represent a realistic

[[Page 29315]]

projection of what CDRH and CBER can accomplish with industry 
cooperation.
    The guidance describes premarket review cycle and decision actions 
and performance goals for premarket notification submissions (510(k)s). 
This guidance document is immediately in effect because the agency 
needs to provide guidance on how it intends to address the performance 
goals it has committed to meeting. On February 4, 2003, FDA published a 
notice in the Federal Register (68 FR 5643) to establish a public 
docket (02N-0534) so that we could share information on the 
implementation of MDUFMA and to provide interested persons an 
opportunity to share their views. On December 3, 2003, the agency held 
an open public meeting to update its stakeholders on its progress in 
implementing the new law, discuss some of MDUFMA's more challenging 
provisions, and obtain input from interested parties. During the 
drafting of this guidance, the agency specifically solicited comments 
to the docket on several aspects of the document in recognition of the 
interest in this issue. The agency has considered all comments received 
to date and will accept comments on the guidance at any time.

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 510(k) review cycle and decision actions and performance goals. 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

    To receive ``FDA and Industry Actions on Premarket Notification 
(510(k)) Submissions: Effect on FDA Review Clock and Performance 
Assessment'' 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 (1219) followed by the pound sign 
([numsign]). 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. 

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 
premarket approval applications (21 CFR part 807, OMB control number 
0910-0120).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, 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.
 Submit 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. Comments received may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11503 Filed 5-20-04; 8:45 am]

BILLING CODE 4160-01-S