[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-P