[Federal Register Volume 67, Number 117 (Tuesday, June 18, 2002)]
[Notices]
[Pages 41432-41433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15209]


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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.

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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