[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31129-31131]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my08-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0366] (formerly Docket No. 2007D-0234)
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Tissue Adhesive for the
Topical Approximation of Skin; 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: Tissue Adhesive for the Topical Approximation of
Skin.'' This guidance document describes a means by which tissue
adhesive for the topical approximation of skin 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
reclassify these device types from class III into class II (special
controls).
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 of the guidance
document entitled ``Class II Special Controls Guidance Document: Tissue
Adhesive for the Topical Approximation of Skin'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
[[Page 31130]]
Rockville, MD 20850. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 240-276-
3151. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: George J. Mattamal, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3619.
SUPPLEMENTARY INFORMATION:
I. Background
Tissue adhesive for the topical approximation of skin devices are
intended for topical closure of surgical incisions, including
laparoscopic incisions, and simple traumatic lacerations that have
easily approximated skin edges. Tissue adhesives for topical
approximation of skin may be used in conjunction with, but not in place
of, deep dermal stitches. This device is currently in class III and
subject to premarket approval requirements (section 515 of the Federal
Food, Drug, and Cosmetic Act (act); 21 U.S.C. 360e).
On August 25, 2006, at a public meeting of FDA's General and
Plastic Surgery Devices Panel (the Panel), the Panel unanimously
recommended that the tissue adhesive for the topical approximation of
skin device be reclassified from class III into class II and
recommended that a guidance document, which the Panel thought should
include several voluntary consensus standards, be the special control
for the device type. FDA considered the Panel's recommendations and, in
the Federal Register of July 3, 2007 (72 FR 36398), published a
proposed rule to reclassify the tissue adhesive for the topical
approximation of skin device into class II. In addition, FDA issued a
draft class II special controls guidance document entitled ``Class II
Special Controls Guidance Document: Tissue Adhesive for the Topical
Approximation of Skin'' to support the proposed reclassification.
Following publication of the draft guidance, four comments on the
guidance were submitted to the FDA. We considered the suggestions and
made appropriate revisions, including consideration of the comments on
testing the applicator. FDA is now identifying the guidance document
entitled ``Class II Special Controls Guidance Document: Tissue Adhesive
for the Topical Approximation of Skin'' as the guidance document that
will serve as the special control for this device type.
The guidance document provides a means by which the tissue adhesive
for the topical approximation of skin device may comply with the
requirement of special controls for this class II device. Following the
effective date of the final reclassification rule, any firm submitting
a premarket notification (510(k)) for a tissue adhesive for the topical
approximation of skin device will need to address the issues covered in
the special controls guidance document. However, the firm need only
show that its device meets the recommendations of the guidance document
or in some other way provides equivalent assurances of safety and
effectiveness. This guidance supersedes the guidance entitled
``Cyanoacrylate Tissue Adhesive for the Topical Approximation of Skin -
Premarket Approval Applications (PMAs),'' dated February 13, 2004.
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 ``Class II Special Controls Guidance
Document: Tissue Adhesive for the Topical Approximation of Skin.'' 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
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Tissue Adhesive for the Topical Approximation of Skin,'' you
may either send an e-mail request to dsmica@fda.hhs.gov to receive an
electronic copy of the document or send a fax request to 240-276-3151
to receive a hard copy. Please use the document number 1630 to identify
the guidance you are requesting.
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 Internet access. 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
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 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
[[Page 31131]]
Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12072 Filed 5-29-08; 8:45 am]
BILLING CODE 4160-01-S