[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]


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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Medical Devices; Draft Guidance for Resorbable Adhesion Barrier 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.

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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availability of the draft guidance entitled, ``Guidance for Resorbable 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This draft guidance is not final nor is it in effect at this time.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draft guidance is being issued because of the increasing interest on 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these products for use in abdominal and/or pelvic surgery, this draft 
guidance was developed to encourage consistency between the two review 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of the draft guidance entitled, ``Guidance for Resorbable Adhesion 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access to the draft guidance.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