[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 20992-20993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8945]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0189]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Low Level Laser 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: Low Level Laser System for Aesthetic Use.'' This
guidance document describes a means by which low level laser 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 low level laser systems for
aesthetic use into class II (special controls). This guidance document
is being immediately implemented as the special control for low level
laser 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 the guidance at
any time. General comments on Agency guidances are welcome at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document: Low
Level Laser System for Aesthetic Use'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Office of
Communication, Education and Radiation Programs, Center for Devices and
Radiological Health (CDRH), 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.
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
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying low level laser 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)).
This guidance document will serve as the special control for low level
laser systems for aesthetic use. 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 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 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. Thus, FDA is issuing this guidance document as a level 1
guidance document that is immediately in effect. FDA will consider any
[[Page 20993]]
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 (21 CFR 10.115). The guidance represents the
Agency's current thinking on low level laser 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
``Class II Special Controls Guidance Document: Low Level Laser 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 1735 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 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: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8945 Filed 4-13-11; 8:45 am]
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