[Federal Register Volume 64, Number 241 (Thursday, December 16, 1999)]
[Notices]
[Pages 70264-70265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-5199]
Medical Devices; Draft Guidance for Resorbable Adhesion Barrier
Devices for Use in Abdominal and/or Pelvic Surgery; 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availability of the draft guidance entitled, ``Guidance for Resorbable
Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery.''
This draft guidance is not final nor is it in effect at this time. This
draft guidance is being issued because of the increasing interest on
the part of sponsors in developing adhesion barrier products and
increasing questions regarding the study requirements for development
of these products. In addition, because two review groups evaluate
these products for use in abdominal and/or pelvic surgery, this draft
guidance was developed to encourage consistency between the two review
groups when they evaluate investigational device exemption (IDE) and
premarket approval application (PMA) applications for these products.
DATES: Submit written comments concerning this guidance by March 16,
2000.
ADDRESSES: Submit written requests for single copies on a 3.5' diskette
of the draft guidance entitled, ``Guidance for Resorbable Adhesion
Barrier Devices for Use in Abdominal and/or Pelvic Surgery'' to the
Division of Small Manufacturers 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. Written comments concerning this guidance must
be submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fisher Lane, rm. 1061, Rockville, MD 20852. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: David B. Berkowitz, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance is being issued because of the increasing
interest on the part of sponsors in developing adhesion barrier
products and in answering questions regarding the study requirements
for development of these products. In addition, because two branches
and divisions are evaluating these products for use in abdominal and/or
pelvic surgery, this guidance was developed to encourage consistency
between the two review groups when they evaluate IDE and PMA
applications for these products.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on resorbable adhesion barrier devices for use in abdominal
and/or pelvic
[[Page 70265]]
surgery. 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 applicable statute,
regulations, or both.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive ``Guidance for Resorbable Adhesion Barrier
Devices for Use in Abdominal and/or Pelvic Surgery'' via your fax
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. At the first voice prompt
press 1 to access DSMA Facts, at the second voice prompt press 2, and
then enter the document number (1356) followed by the pound sign (#).
Then follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the Internet. The Center for Devices and Radiological
Health (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 access to the Internet. Updated on a
regular basis, the CDRH home page includes the draft guidance entitled
``Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal
and/or Pelvic Surgery,'' device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh.
IV. Comments
Interested persons may, on or before March 16, 2000, submit to
Dockets Management Branch (address above) written comments regarding
this draft guidance. Two copies of any comments are to be submitted,
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 draft guidance and received comments may be seen in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: December 7, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-32589 Filed 12-15-99; 8:45 am]
BILLING CODE 4160-01-F