[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36473-36474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12795]


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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Class II Special Controls 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 This draft guidance document describes a means by which the 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 This draft guidance is not final nor 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 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    Submit written comments concerning this draft guidance to the 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://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 [email protected] 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://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 Division of Dockets Management Internet site at 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