[Federal Register Volume 79, Number 244 (Friday, December 19, 2014)]
[Notices]
[Pages 75821-75822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29725]
[[Page 75821]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1092]
Minimizing Risk for Children's Toy Laser Products; Guidance for
Industry and Food and Drug Administration Staff; 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 ``Minimizing Risk for Children's
Toy Laser Products.'' This guidance is intended to inform manufacturers
of laser products, FDA headquarters and field personnel, and the public
of the Center for Devices and Radiological Health's (CDRH) current
thinking on the safety of children's toy laser products and to provide
specific safety recommendations for the manufacture and labeling of
children's toy laser products.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Minimizing Risk for Children's Toy Laser Products'' to the Office of
the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
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: Daniel Hewett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993-0002, 301-796-5864.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance is intended to inform manufacturers of laser
products, FDA headquarters and field personnel, and the public of
CDRH's current thinking on the safety of children's toy laser products.
Lasers with outputs above certain levels that are operated in an unsafe
and uncontrolled manner may cause injury to the user and/or others
within range of the laser beam. This is a particular concern for lasers
intended for entertainment purposes, especially when intended to be
used as toys by children.
Federal law requires that, other than for certain exceptions, laser
products manufactured or assembled after August 1, 1976, must be in
compliance with the federal performance standards for laser products
(21 CFR 1040.10 and 1040.11). At present FDA regulations do not
specifically identify what constitutes children's toy laser products.
In the Federal Register of June 24, 2013, FDA issued a proposed rule
that proposed to define children's toy laser products and require them
to be within the International Electrotechnical Commission (IEC) Class
1 emission limit (see proposed 21 CFR 1040.10(b)(1), (2) and 1040.11(d)
at 78 FR 37723 (June 24, 2013)). While this rulemaking process is
ongoing, CDRH recommends that manufacturers keep children's toy laser
products within the FDA Class I or IEC Class 1 emission limits in order
to minimize the risk they pose to users and/or others in range of the
laser beam, including the vulnerable population for whom they are
intended. For those children's toy laser products that meet the
definition of a ``demonstration laser product'' or ``surveying,
leveling, or alignment laser product,'' CDRH will not object to
compliance with the International Electrotechnical Commission Class I
emission limit (set forth in IEC 60825-1:2007). To that end, this
guidance supersedes in part the policy set forth in the Guidance on
Laser Products--Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser
Notice No. 50), which will cease to be effective by its own terms upon
the effective date of amendments to the regulations applicable to laser
products. (Ref. #1). However, because IEC Classes 1M and 2M do not have
comparable analogs in FDA's classification system, manufacturers should
not conform to the parameters for IEC Classes 1M or 2M unless they also
comply with FDA's performance standards for laser products.
In the Federal Register of August 7, 2013 (78 FR 48172), the Agency
issued the draft guidance entitled ``Minimizing Risk for Children's Toy
Laser Products--Draft Guidance for Industry and Food and Drug
Administration Staff.'' The Agency received two comments on the 2013
draft guidance and has incorporated most of the recommendations in this
final guidance.
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 children's toy laser products. 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
downloading an electronic copy from 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. Persons unable to download an electronic copy of
``Minimizing Risk for Children's Toy Laser Products'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1810 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to a previously approved collection of
information found in FDA regulations. This collection of information is
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
collection of information in part 1040 is approved under OMB control
number 0910-0025.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and
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will be posted to the docket at http://www.regulations.gov.
VI. References
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
1. FDA Guidance on Laser Products--Conformance with IEC 60825-1 and IEC
60601-2-22 (Laser Notice No. 50) (June 2007), available at http://www.fda.gov/downloads/MedicalDevices/.../ucm094366.pdf.
Dated: December 15, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29725 Filed 12-18-14; 8:45 am]
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