[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Notices]
[Page 33165-33166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn03-89]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance
documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Dockets Management Branch
Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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