[Federal Register: July 3, 2007 (Volume 72, Number 127)]
[Notices]
[Page 36473-36474]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy07-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0234]
Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Tissue Adhesive for the Topical Approximation of
Skin.'' This draft guidance document describes a means by which the
tissue adhesive for the topical approximation of skin may comply with
the requirement of
[[Page 36474]]
special controls for class II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a proposed rule to reclassify
tissue adhesive for the topical approximation of skin from class III
into class II (special controls). This draft guidance is not final nor
is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by September 4, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance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., 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Submit written comments concerning this draft guidance to the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.fda.gov/dockets/ecomments. 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. FDA considered the Panel's recommendations and,
elsewhere in this issue of the Federal Register, is proposing to
reclassify the tissue adhesive for the topical approximation of skin
device into class II. If this reclassification rule is finalized, FDA
intends that this guidance document will serve as the special control
for this device.
Following the effective date of any final reclassification rule
based on this proposal, any firm submitting a premarket notification
(510(k)) for a tissue adhesive for the topical approximation of skin
device would 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.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, if
finalized, will represent the agency's current thinking on tissue
adhesive for the topical approximation of skin devices. 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 draft 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 on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
This draft 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 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; the collections
of information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130; and the collections of information in 21 CFR
part 801 have been approved under OMB control number 0910-0485.
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 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.
Dated: June 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-12795 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S