[Federal Register: September 15, 2005 (Volume 70, Number 178)]
[Page 54561-54562]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005D-0348]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Procedures for Handling Post-Approval Studies Imposed by 
Premarket Approval Application Order; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Procedures for Handling 
Post-Approval Studies Imposed by PMA Order.'' The draft guidance is 
designed to assist the Center for Devices and Radiological Health 
(CDRH) and sponsors to meet their responsibilities to track post-
approval studies (sometimes called Condition of Approval Studies) that 
are mandated for market approval of medical devices.

DATES: Submit written or electronic comments on this draft guidance by 
November 14, 2005.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Procedures for 
Handling Post-Approval Studies Imposed by PMA Order'' 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 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
    Submit written comments concerning this draft guidance to the 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 

Surveillance and Biometrics, Division of Postmarket Surveillance, 
Center for Devices and Radiological Health (HFZ-500), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3674

[[Page 54562]]


I. Background

    The draft guidance is designed to assist sponsors and CDRH to 
oversee post-approval studies. These studies are oftentimes mandated at 
the time the Center approves a Premarket Approval Application (PMA) to 
address additional concerns. This guidance aims to assure that:
     Sponsors submit clear, consistent and timely study 
     CDRH can track the status of the studies;
     CDRH staff reviews the studies and holds discussions with 
the sponsors in a timely manner;
     CDRH stakeholders can quickly learn about the status of 
these studies; and
     CDRH can take appropriate and timely action based on study 

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on ``Procedures 
for Handling Post-Approval Studies Imposed by PMA Order.'' 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 

III. Electronic Access

    To receive ``Procedures for Post-Approval Studies Imposed by PMA 
Order'' 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 (1516) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
    Persons interested in obtaining a copy of the draft 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 draft 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 USC 3501-3520). The 
collections of information addressed in the draft guidance document 
have been approved by OMB in accordance with the PRA under the 
regulations governing premarket approval applications (21 CFR part 814, 
OMB control number 0910-0231).

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 or 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. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18372 Filed 9-14-05; 8:45 am]