Document ID: FDA-2011-D-0500-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use
Posted Date: 2011-07-20T04:00Z

[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Notices]
[Pages 43332-43333]
From the Federal Register Online via the Government Printing 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 dsmica@fda.hhs.gov 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]
BILLING CODE 4160-01-P