[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Notices]
[Pages 77797-77798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0289]


Medical Devices; Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA; 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 ``Class II Special Controls 
Guidance Document: Surgical Sutures; Guidance for Industry and FDA.'' 
This guidance will serve as a special control for the absorbable 
polydioxanone surgical (PDS) suture which is being reclassified from 
class III to class II (special controls) elsewhere in this issue of the 
Federal Register. This guidance document is immediately in effect as 
the special control for the absorbable PDS suture, but it remains 
subject to comment in accordance with the agency's good guidance 
practices (GGPs).
    Also, elsewhere in this issue of the Federal Register, FDA is 
publishing a proposed rule to amend eight other surgical suture device 
classification regulations in order to designate this guidance as the 
special control for each such device. After public comments are 
reviewed, FDA intends to issue a final rule for the eight other 
surgical sutures and make this guidance effective as the special 
control guidance for those sutures in addition to the PDS suture, for a 
total of nine suture types. This guidance is not final nor is it in 
effect at this time for the eight surgical sutures for which it is 
being proposed as a special control.

DATES: Submit written or electronic comments concerning this guidance 
by March 19, 2003.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Surgical Sutures; Guidance for Industry and 
FDA'' 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.

[[Page 77798]]

    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. Comments should be identified 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: Anthony D. Watson, 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 guidance document describes a means by which surgical suture 
devices may comply with the requirement of special controls for class 
II devices. Designation of this guidance document as a special control 
means that a manufacturer attempting to establish that its device is 
substantially equivalent to a predicate class II surgical suture should 
demonstrate that the proposed device complies with either the specific 
recommendations of this guidance or some alternate control that 
provides equivalent assurances of safety and effectiveness.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices (GGPs) regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on ``Class II Special Controls Guidance 
Document: Surgical Sutures; Guidance for Industry and FDA.'' 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 ``Class II Special Controls Guidance Document: 
Surgical Sutures; Guidance for Industry and FDA,'' 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 (1387) followed by the pound sign ([numsign]). Follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so 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. 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. The CDRH home page may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Dockets Management Branch Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This 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 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR part 807, subpart E were 
approved under OMB control number 0910-0120.

V. Comments

    You may submit to Dockets Management Branch (see ADDRESSES) written 
or electronic comments regarding this guidance by March 19, 2003. 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 
comments received may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 16, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-31992 Filed 12-18-02; 8:45 am]
BILLING CODE 4160-01-S