[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Notices]
[Pages 43332-43333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18280]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0500]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Focused Ultrasound
Stimulator 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: Focused Ultrasound Stimulator System for Aesthetic
Use.'' This guidance document describes a means by which focused
ultrasound stimulator systems for aesthetic use may comply with the
requirement of special controls for class II devices. This guidance
document is being immediately implemented as the special control for
focused ultrasound stimulator systems for aesthetic use, but it remains
subject to comment in accordance with the Agency's good guidance
practices.
DATES: Submit either electronic or written comments on this 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:
Focused Ultrasound Stimulator 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:
I. Background
This guidance document will serve as the special control for
focused ultrasound stimulator systems for aesthetic use. Section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(f)(2)) 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 FDA to classify the device
under the criteria set forth in section 513(a)(1) of the FD&C Act. FDA
shall, within 60
[[Page 43333]]
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 FD&C Act, FDA has determined, under 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. Thus, 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.
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying focused ultrasound stimulator systems for
aesthetic use into class II (special controls) under section 513(f)(2)
of the FD&C Act.
II. Significance of Guidance
FDA believes that adherence to the recommendations described in
this guidance document, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of focused
ultrasound stimulator system for aesthetic use classified under
878.4590 (21 CFR Part 878). In order to be classified as a class II
device under 878.4590, an ultrasound stimulator for aesthetic use must
comply with the requirements of special controls; a manufacturer must
address the issues requiring special controls as identified in the
guidance, either by following the recommendations in the guidance
document or by some other means that provides equivalent assurances of
safety and effectiveness.
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: Focused Ultrasound
Stimulator System for Aesthetic Use,'' 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 301-847-8149 to receive a hard copy.
Please use the document number 1701 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 Part 812 have been approved under OMB control
number 0910-0078; 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 50.23 have been approved under OMB control number
0910-0586; 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: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18280 Filed 7-19-11; 8:45 am]
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