Document ID: FDA-2014-D-2245-0001
Agency: fda
Document Type: Notice
Title: Immediately in Effect Guidance Document: Classification and
Requirements for Laser Illuminated Projectors; Guidance for Industry and
Food and Drug Administration Staff; Availability
Posted Date: 2015-02-18T05:00Z

[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8665-8666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03209]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2245]

Immediately in Effect Guidance Document: Classification and 
Requirements for Laser Illuminated Projectors; 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 ``Immediately in Effect Guidance 
Document: Classification and Requirements for Laser Illuminated 
Projectors (LIPs).'' This guidance describes FDA's policy with respect 
to certain LIPs that comply with International Electrotechnical 
Commission (IEC) standards during laser product classification under 
the Electronic Product Radiation Control provisions of the Federal 
Food, Drug and Cosmetic Act (the FD&C Act) that apply to electronic 
products.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment, submit 
either electronic or written comments on the guidance by April 20, 
2015.

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 
``Immediately in Effect Guidance Document: Classification and 
Requirements for Laser Illuminated Projectors'' 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: Patrick Hintz, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4248, Silver Spring, MD 20993-0002, 301-796-6927.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Immediately in Effect Guidance Document: 
Classification and Requirements for Laser Illuminated Projectors.'' 
This guidance is being issued consistent with FDA's good guidance 
practices (GGPs) regulation (21 CFR 10.115). The guidance is being 
implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (21 CFR 10.115(g)(2)). The Agency made this determination 
because the guidance presents a less burdensome policy consistent with 
the public health. Although this guidance is immediately in effect, it 
remains subject to comment in accordance with the Agency's GGPs 
regulation. This guidance describes FDA's policy with respect to 
certain LIPs that comply with IEC standards during laser product 
classification under the Electronic Product Radiation Control 
provisions of the FD&C Act that apply to electronic products. The 
regulations for classifying laser products are set forth in part 1040 
(21 CFR part 1040).
    For purposes of this guidance, the term ``laser illuminated 
projector'' refers to a type of demonstration laser product regulated 
under Sec.  1040.10(b)(13) that is designed to project full-frame 
digital images. The term ``demonstration laser product'' is defined 
under Sec.  1040.10(b)(13) to mean, ``Any laser product manufactured, 
designed, intended, or promoted for purposes of demonstration, 
entertainment, advertising display, or artistic composition.'' LIPs may 
be used in locations such as indoor or outdoor cinema theaters, laser 
shows, presentations at conventions, as image/data projectors in an 
office setting, or in a home.
    Lasers are being used in LIPs as an alternative to conventional 
lamps in

[[Page 8666]]

projectors. Although these LIPs emit laser light from extended sources 
and their uncollimated beams do not present the same hazards as other 
lasers, they are laser products that present risks and must undergo 
classification in accordance with Sec.  1040.10(c).
    Under Sec.  1040.10(c), FDA recognizes four major hazard classes (I 
to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). 
Under this classification procedure, higher laser classes correspond to 
more powerful lasers and the potential to pose serious danger if used 
improperly.
    As demonstration laser products, LIPs cannot exceed class IIIa 
(which is comparable to IEC class 3R) emissions limits as specified in 
Sec.  1040.11(c) unless granted a variance by FDA under Sec.  1010.4. 
Many LIPs and applications for LIPs will exceed the class IIIa limits 
and therefore require a variance to exceed those emission limits.
    This guidance document describes FDA's intent with regard to the 
application of certain aspects of the performance standard requirements 
in Sec.  1040.11(c) for LIPs. The IEC standards used to evaluate lamps 
are applicable to characterizing ocular hazards in LIPs, because a 
laser retinal hazard is related to the radiance of the laser source and 
the radiant emission levels produced by LIPs are comparable to 
conventional lamps. Because the radiant emission levels produced by 
LIPs can scientifically be characterized by an alternative IEC 
standard, FDA does not intend to consider whether LIP manufacturers 
that conform to these standards under the situations described in this 
guidance also comply with Sec. Sec.  1040.10(c) and 1040.11(c).

II. Significance of Guidance

    The guidance represents the Agency's current thinking on the 
classifications and requirements for LIPs. 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 Center for Devices and Radiological Health 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 ``Immediately in Effect 
Guidance Document: Classification and Requirements for Laser 
Illuminated Projectors'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1400056 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 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 1002, 1010, and 
1040 are approved under OMB control number 0910-0025.
    The labeling referenced in section (IV)(c)(ii) of the guidance does 
not constitute a ``collection of information'' under the PRA because 
the labeling is a ``public disclosure of information supplied by the 
Federal Government to the recipient for the purpose of disclosure to 
the public'' (5 CFR 1320.3(c)(2)).

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 will be posted to the docket at http://www.regulations.gov.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03209 Filed 2-17-15; 8:45 am]
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