[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20143-20145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09380]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Classification and Requirements for Laser Illuminated Projectors 
(Laser Notice No. 57); Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Classification and 
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 
57).'' 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 (FD&C Act) that apply to electronic products.

DATES: The announcement of the guidance is published in the Federal 
Register on May 8, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management

[[Page 20144]]

Staff, FDA will post your comment, as well as any attachments, except 
for information submitted, marked and identified, as confidential, if 
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-2245 for ``Classification and Requirements for Laser 
Illuminated Projectors (LIPs) (Laser Notice No. 57); Guidance for 
Industry and Food and Drug Administration Staff.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Classification and Requirements for Laser Illuminated Projectors 
(LIPs) (Laser Notice No. 57)'' to the Office of Policy, 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.

FOR FURTHER INFORMATION CONTACT: Patrick Hintz, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927.

SUPPLEMENTARY INFORMATION: 

I. Background

    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 (Pub. L. 90-602, amended by Pub. L. 103-80) that apply to 
electronic products. For purposes of this guidance, the term ``laser 
illuminated projector'' refers to a type of demonstration laser product 
regulated under 21 CFR 1040.10(b)(13) that is designed to project a 
display image without the use of raster-scanned collimated laser beams. 
LIPs may be used in locations such as indoor or outdoor cinema 
theaters, laser shows, presentations at conventions, image/data 
projectors in office settings, or homes. Under 21 CFR 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 a 
higher potential to pose serious danger if used improperly.
    As demonstration laser products, LIPs and applications for LIPs 
cannot exceed class IIIa emission limits as specified in 21 CFR 
1040.11(c) (which is comparable to IEC 60825-1 Ed. 3.0 Class 3R) unless 
granted a variance by FDA under 21 CFR 1010.4. Some 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 to clarify the 
application of certain aspects of the performance standard requirements 
in 21 CFR 1040.11(c) for LIPs. Because the radiant emission levels 
produced by LIPs can be scientifically characterized by an alternative 
IEC standard, IEC 62471-5:Ed. 1.0, FDA does not intend to enforce the 
requirements under 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c) when LIP 
manufacturers conform to these standards under the situations outlined 
in sections III and IV of this guidance.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of October 2, 2017 (82 FR 45861). FDA 
revised the guidance as appropriate in response to the comments. This 
guidance supersedes ``Immediately in Effect Guidance Document: 
Classification and Requirements for Laser Illuminated Projectors 
(LIPs); Guidance for Industry and Food and Drug Administration Staff,'' 
issued February 18, 2015.

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 
current thinking of FDA on classification and requirements for LIPs 
(Laser Notice No. 57). It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations. This guidance is not subject to Executive Order 12866.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Classification and 
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 
57)'' 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. 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

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of information in the following FDA regulations and forms have been 
approved by OMB as listed in the following table:

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                                                            OMB control
      21 CFR part and form                Topic                 No.
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1002, 1010, 1040, and form FDA   Reporting and                 0910-0025
 3632.                            Recordkeeping for
                                  Electronic Products--
                                  General Requirements.
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    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09380 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P


