[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69089-69090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0514]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Tissue Adhesive With 
Adjunct Wound Closure Device Intended 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 with Adjunct Wound Closure Device 
Intended for the Topical Approximation of Skin.'' This guidance 
document describes a means by which tissue adhesives with adjunct wound 
closure devices intended 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 classify tissue adhesive with adjunct wound closure 
device intended for the topical approximation of skin into class II 
(special controls). This guidance document is immediately in effect as 
the special control for tissue adhesive with adjunct wound closure 
device intended for approximation of skin, but it remains subject to 
comment in accordance with the agency's good guidance practices (GGPs).

DATES: Submit either electronic or written comments on the guidance at 
any time. General comments on agency guidance 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 with Adjunct Wound Closure Device Intended for the Topical 
Approximation of Skin'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6396.

SUPPLEMENTARY INFORMATION: 

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying tissue adhesive with adjunct wound closure 
device intended for the topical approximation of skin into class II 
(special controls), under section 513(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)). This guidance 
document will serve as the special control for the tissue adhesive with 
adjunct wound closure device intended for the topical approximation of 
skin device. Section 513(f)(2) of the FD&C Act provides that any person 
who submits a premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) for a device that has not previously been 
classified may, within 30 days after receiving an order classifying the 
device in class III

[[Page 69090]]

under section 513(f)(1) of the FD&C Act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the FD&C 
Act. FDA shall, within 60 days of receiving such a request, classify 
the device by written order. This classification shall be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing such classification. Because of the timeframes 
established by section 513(f)(2) of the act, FDA has determined, under 
Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to 
allow for public participation before issuing this guidance as a final 
guidance document. Therefore, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately in effect. FDA will 
consider any comments that are received in response to this notice to 
determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
agency's current thinking on tissue adhesive with adjunct wound closure 
device intended for 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. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: Tissue Adhesive with 
Adjunct Wound Closure Device Intended for the Topical Approximation of 
Skin,'' you may either send an email request to [email protected] to 
receive an electronic copy of the document or send a fax request to 
301-796-8149 to receive a hard copy. Please use the document number 
1683 to identify the guidance you are requesting.

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 parts 50 and 56 have been approved under OMB 
control number 0910-0130; 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 part 58 have been approved under 
OMB control number 0910-0119; 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), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: November 4, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28333 Filed 11-9-10; 8:45 am]
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