[Federal Register: September 15, 2005 (Volume 70, Number 178)]
[Notices]
[Page 54561-54562]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se05-45]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Draft Guidance for Industry and Food and Drug Administration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.
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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availability of the draft guidance entitled ``Procedures for Handling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 The draft guidance is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DATES: Submit written or electronic comments on this draft guidance by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diskette of the draft guidance document entitled ``Procedures for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INFORMATION section for information on electronic access to the draft
guidance.
Submit written comments concerning this draft guidance to the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
document.
FOR FURTHER INFORMATION CONTACT: Steven H. Chasin, Office of
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]]
SUPPLEMENTARY INFORMATION:
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
reports;
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
results.
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
regulations.
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
request.
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]
BILLING CODE 4160-01-S