[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20140-20142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-7011]


Laser Products--Conformance With IEC 60825-1 Ed. 3 and IEC 60601-
2-22 Ed. 3.1 (Laser Notice No. 56); 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 for industry entitled ``Laser 
Products--Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 
(Laser Notice No. 56).'' This guidance describes the Agency's approach 
regarding compliance with FDA's performance standards for laser 
products. FDA believes that under the circumstances described in this 
guidance, conformance with certain International Electrotechnical 
Commission (IEC) standards would provide adequate protection of the 
public health and safety for laser products similar to performance 
standards in FDA's regulations. Accordingly, for laser product 
manufacturers that comply with the comparable clauses in IEC standards 
specified in the guidance, FDA does not intend to enforce the specified 
laser performance standards in FDA's regulations.

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 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-2017-D-7011 for ``Laser Products--Conformance with IEC 60825-1 Ed. 
3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' 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

[[Page 20141]]

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 
``Laser Products--Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 
Ed. 3.1 (Laser Notice No. 56)'' 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

    FDA recognizes that the IEC is a global organization that prepares 
and publishes international standards for electrical, electronic, and 
related technologies, including laser products. This means that 
manufacturers distributing products in the United States and other 
countries might have to ensure conformance of their products with IEC 
standards as well as comply with FDA regulatory requirements. Complying 
with FDA regulations and conforming to the identified IEC standards may 
cause manufacturers to duplicate their efforts.
    FDA acknowledges the advantages of a universal set of device-
specific criteria and requirements. Moreover, FDA believes that under 
the circumstances described in this guidance, conformance with certain 
IEC standards would provide adequate protection of the public health 
and safety for laser products similar to FDA's performance standards in 
Sec. Sec.  [thinsp]1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11). 
FDA eventually intends to amend its standards for laser products at 
Sec. Sec.  [thinsp]1040.10 and 1040.11 to harmonize many of its 
requirements with those of the IEC because FDA acknowledges the 
advantages of one set of criteria and requirements worldwide. Until 
these requirements are harmonized, for laser product manufacturers that 
comply with the comparable clauses in IEC 60825-1 Ed. 3 and IEC 60601-
2-22 Ed. 3.1, FDA does not intend to enforce the comparable 
requirements in Sec. Sec.  1040.10 and 1040.11.
    On June 24, 2007, FDA's Center for Devices and Radiological Health 
(CDRH) published a guidance entitled ``Laser Products--Conformance with 
IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff 
(Laser Notice No. 50)'' (https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/laser-products-conformance-iec-60825-1-and-iec-60601-2-22-laser-notice-no-50). Laser Notice No. 56 will not replace the recommendations provided 
in that 2007 guidance, and manufacturers can follow either Laser Notice 
No. 50 or 56.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of January 19, 2018 (83 FR 2789). FDA 
revised the guidance as appropriate in response to the comments.

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 ``Laser Products--Conformance with IEC 
60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' 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 ``Laser Products--
Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser 
Notice No. 56)'' may send an email request to CDRH-Guidance@fda.hhs.gov 
to receive an electronic copy of the document. Please use the document 
number 1500024 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 of information in 
the following FDA regulations have been approved by OMB as listed in 
the following table:

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                                                            OMB control
         21 CFR parts                    Topic                  No.
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1002, 1010, 1040.............  Reporting and                   0910-0025
                                Recordkeeping for
                                Electronic Products--
                                General Requirements.
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    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09381 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P


