Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability, 31129-31131 [E8-12072]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 105 (Friday, May 30, 2008)]
[Notices]
[Pages 31129-31131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12072]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at https://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 https://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