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.

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 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.