[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Notices]
[Pages 33165-33166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13826]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0289]


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 eight surgical suture 
devices. This guidance document describes a means by which surgical 
sutures may comply with the requirement of special controls for class 
II devices. Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to amend the classification regulations for 
eight surgical suture devices previously reclassified into class II to 
specify a special control for those devices.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the 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. 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, ext. 164.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Class 
II Special Controls Guidance Document: Surgical Sutures; Guidance for 
Industry and FDA.'' 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 will need to address the recommendations in this 
special control guidance. However, the firm need only show that its 
device is as safe and effective as a device that meets guidance 
recommendations. The firm may use alternative approaches if those 
approaches address the performance, testing, and labeling issues 
identified in the guidance. This guidance supercedes ``Class II Special 
Controls Guidance Document: Surgical Sutures; Guidance for Industry and 
FDA'' issued on December 19, 2002.

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 surgical sutures. 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 statutes and regulations.

III. Paperwork Reduction Act of 1995

    The 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 addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB control number 0910-0120). The labeling provisions addressed in 
the guidance have been approved by OMB under the PRA under OMB control 
number 0910-0485.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document at 
any time. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Surgical 
Sutures; Guidance for Industry and FDA'' by fax, 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 by using the Internet. CDRH maintains a site on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including

[[Page 33166]]

lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site 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.

    Dated: May 20, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-13826 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S