
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45861-45863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21079]


-----------------------------------------------------------------------

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(Laser Notice No. 57); Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Classification and 
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 
57); Draft Guidance for Industry and Food and Drug Administration 
Staff.'' When finalized, 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. When finalized, this document will supersede the 
``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. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 1, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic submissions as follows:
     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 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.''

[[Page 45862]]

    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); Draft 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 draft guidance document entitled 
``Classification and Requirements for Laser Illuminated Projectors 
(LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and 
Drug Administration Staff'' 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.

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

    When finalized, this guidance describes FDA's policy with respect 
to certain laser illuminated projectors 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'' (LIP) refers to a type of demonstration laser product 
regulated under 21 CFR 1040.10(b)(13) that is designed to project full-
frame digital images. 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.
    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. 2.0 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 62471-5:2015, FDA does not intend to consider whether 
LIP manufacturers that conform to these standards under the situations 
outlined in sections III and IV of this guidance also comply with 21 
CFR 1040.10(c)(1) and 21 CFR 1040.11(c). For LIP manufacturers who 
choose not to conform to these standards under the situations outlined 
in sections III and IV of this guidance, such manufacturers should 
evaluate these laser products in accordance with FDA's guidance 
entitled ``Laser Products--Conformance with IEC 60825-1 and IEC 60601-
2-22 (Laser Notice No. 50); Guidance for Industry and FDA Staff'' 
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094361.htm) or must continue to comply with 21 CFR 
1040.10(c) and 21 CFR 1040.11(c), among other applicable requirements.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on classification 
and requirements for laser illuminated projectors. 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 draft 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. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Classification and Requirements for Laser 
Illuminated Projectors (Laser Notice No. 57); Draft Guidance for 
Industry and Food and Drug Administration Staff'' 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.

[[Page 45863]]

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 parts 1002, 1010, and 1040 are 
approved under OMB control number 0910-0025.

    Dated: September 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21079 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P


