[Federal Register: June 18, 2002 (Volume 67, Number 117)]
[Notices]
[Page 41432-41433]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn02-59]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-5199]
Medical Devices; 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 guidance entitled ``Guidance for Resorbable
Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery.''
This guidance is intended to provide guidance on the preclinical
testing recommended for resorbable adhesion barrier devices used in
abdominal and/or pelvic surgery. This guidance is being issued to
finalize the previous draft version issued on December 16, 1999.
DATES: Submit written or electronic comments concerning this guidance
at any time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Guidance for Resorbable
Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery''
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. Submit
written comments concerning this guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document. Submit electronic
comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Joyce M. Whang, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document is intended to provide guidance on the
preclinical and clinical testing recommended for resorbable adhesion
barrier devices used in abdominal and/or pelvic surgery. It was
developed jointly by the Division of General, Restorative and
Neurological Devices, and the Division of Reproductive, Abdominal and
Radiological Devices. The final version of this guidance supersedes the
draft
[[Page 41433]]
version published in the Federal Register on December 16, 1999 (64 FR
70264). The comment period for the draft guidance ended on March 15,
2000. A meeting of the Obstetrics and Gynecology Devices Panel was held
on January 25, 2000, to discuss the draft version of this guidance.
Comments received on the draft guidance generally addressed the use
of adhesion reduction as a surrogate endpoint for clinical endpoints
such as fertility, pelvic pain, and small bowel obstruction. Several
respondents stated that adhesion reduction itself should be considered
an endpoint that provides a clinical benefit to the patient
irrespective of other clinical outcomes such as those mentioned above.
The agency believes that whether adhesion reduction is considered a
surrogate or clinical endpoint, it is valid as a study endpoint so long
as the adhesion reduction measured provides some reasonable assurance
that the adhesion barrier will provide clinically significant results.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on resorbable adhesion barrier devices used
in abdominal and/or pelvic 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 requirements of the applicable statute and regulations.
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 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 (1356) followed by the pound sign ([numsign]). Follow the
remaining voice prompts to complete your request.
You may obtain a copy of the guidance from the Internet. CDRH
maintains an entry on the Internet for easy access to information
including text, graphics, and files that you may download to a personal
computer. 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 manufacturers' assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. You may access the CDRH home
page at http://www.fda.gov/cdrh. You may search for all CDRH guidance
documents at http://www.fda.gov/cdrh/guidance.html. Guidance documents
are also available on the Dockets Management Branch Web site at http://
www.fda.gov/ohrms/dockets.
IV. Comments
You may submit to the Dockets Management Branch (see ADDRESSES)
written or electronic comments regarding this guidance at any time. You
should submit two copies of any comments. Individuals may submit one
copy. You must identify comments with the docket number found in
brackets in the heading of this document. The guidance document and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 31, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-15209 Filed 6-17-02; 8:45 am]
BILLING CODE 4160-01-S