[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6622-6623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2553]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0645]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Contact Cooling System for
Aesthetic Use; 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: Contact Cooling System for Aesthetic Use.'' This
guidance document describes a means by which contact cooling systems
for aesthetic use 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 contact cooling systems for
aesthetic use into class II (special controls). The guidance document
is immediately in effect as the special control for cooling system for
aesthetic use, but it remains subject to comment in accordance with the
Agency's good guidance practices (GGPs).
DATES: Submit 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:
Contact Cooling System for Aesthetic Use'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, 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: Richard Felten, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1436, Silver Spring, MD 20993-0002, 301-796-6392.
SUPPLEMENTARY INFORMATION:
[[Page 6623]]
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying contact cooling systems for aesthetic use 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)). The
guidance document will serve as the special control for contact cooling
systems for aesthetic use 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 under section 513(f)(1) of
the FD&C Act, request that FDA 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 time frames established by section
513(f)(2) of the FD&C 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 the guidance as a final guidance document.
Therefore, FDA is issuing the 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
The guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
Agency's current thinking on contact cooling systems for aesthetic use.
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
a hard copy of ``Class II Special Controls Guidance Document: Contact
Cooling System for Aesthetic Use,'' you may send a fax request to 301-
847-8149. Please use the document number 1734 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
The 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 (the PRA) (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 812 have been approved under OMB control
number 0910-0078; the collection of information 21 CFR 50.23 have been
approved under OMB control number 0910-0586; the collections of
information in 21 CFR 56.115 have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 58 have
been approved under OMB control number 0910-0119; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in 21 CFR 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: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2553 Filed 2-4-11; 8:45 am]
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