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, 20140-20142 [2019-09381]

Download as PDF 20140 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Annual frequency per recordkeeper Number of respondents 21 CFR Section Total annual records Hours per record Total hours 807.25(d) 2—List of Officers, Directors, and Partners 807.26 2—Labeling and Advertisements Available for Review. 22,338 17,032 1 4 22,338 68,128 0.25 (15 minutes) .... 0.5 (30 minutes) ...... 5,585 34,064 Total .................................................................... ........................ ........................ ........................ .................................. 39,649 1 There are no capital costs or operating and maintenance costs associated with this collection of information. burden—Firm is required to keep records. 2 Recurring The following adjustments and program changes resulted in a 5,672hour decrease to the overall total hour burden estimate for this information collection request. • We adjusted the number of respondents based on updated registration and listing data. • In the reporting burden table, we corrected the table footnotes to accurately indicate whether the information collection (IC) is a one-time or reoccurring burden. • We also adjusted some of the IC descriptions in the table for increased clarity. • We updated our estimate of Hours per Response for ‘‘807.22(a) Initial Registration and Listing’’ (+ 0.5 hours), ‘‘807.22(b)(1) Annual Registration’’ (¥ 0.25 hours), and ‘‘807.22(b)(3) Annual Update of Listing Information’’ (¥ 0.25 hours). Based on our review of the program, we believe these changes to the burden estimate will more accurately reflect the current preparation time for these ICs. Dated: May 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–09412 Filed 5–7–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–7011] khammond on DSKBBV9HB2PROD with NOTICES 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. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Laser Products—Conformance with IEC SUMMARY: VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 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. The announcement of the guidance is published in the Federal Register on May 8, 2019. DATES: You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: 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. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 • 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 E:\FR\FM\08MYN1.SGM 08MYN1 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices khammond on DSKBBV9HB2PROD with NOTICES 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/201523389.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 §§ 1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11). FDA eventually intends to amend its standards for laser products at §§ 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 §§ 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/medicaldevices/guidance-documents-medicaldevices-and-radiation-emittingproducts/laser-products-conformanceiec-60825-1-and-iec-60601-2-22-lasernotice-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: OMB control No. 21 CFR parts Topic 1002, 1010, 1040 ... Reporting and Recordkeeping for Electronic Products—General Requirements ........................................... VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 20141 E:\FR\FM\08MYN1.SGM 08MYN1 0910–0025 20142 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices Dated: May 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St, North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. [FR Doc. 2019–09381 Filed 5–7–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3353] Antimicrobial Animal Drug Distribution Reports and Recordkeeping—21 CFR 514.87 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping AGENCY: OMB Control Number 0910–0659— Extension Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 7, 2019. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0659. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) to submit to FDA an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. Sponsors are also required to maintain distribution records for their animal drug products, including separate information for each month of the calendar year, under section 512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA in our continuing analysis of the interactions (including drug resistance), efficacy, and safety of antimicrobials approved for use in both humans and food-producing animals for the purpose of mitigating the public health risk associated with antimicrobial resistance. Section 514.87 of our regulations (21 CFR 514.87) codifies the reporting requirements established in the FD&C Act. Sponsors submit antimicrobial animal drug sales and distribution reports to the Agency on Form FDA 3744. Each report must specify: (1) The amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. Each report must also provide a species-specific estimate of the percentage of each product that was sold or distributed domestically in the reporting year for use in cattle, swine, chickens, or turkeys for such species that appear on the approved label. Collection of information on the amount of animal antimicrobials being distributed, including species-specific information, is necessary to support our ongoing efforts to encourage the judicious use of antimicrobials in foodproducing animals to help ensure the continued availability of safe and effective antimicrobials for animals and humans. We intend to use these data to supplement existing information, including data collected under the National Animal Health Monitoring System and the National Antimicrobial Resistance Monitoring System programs. Data from multiple sources are needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture. In the Federal Register of October 1, 2018 (83 FR 49395), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 khammond on DSKBBV9HB2PROD with NOTICES 21 CFR section FDA form 514.87(a) through (e)—Annual Reports for Sponsors With Active Applications—Paper Submission ..................... 514.87(a) through (e)—Annual Reports for Sponsors With Active Applications—Electronic Submission ............... 514.87(a) through (e)—Annual Reports for Sponsors With Inactive Applications—Paper Submission ..................... 514.87(a) through (e)—Annual Reports for Sponsors With Inactive Applications—Electronic Submission ............... Total .................................................. 1 There Number of responses per respondent Number of respondents Average burden per response Total annual responses 3744 10 7.5 75 62 4,650 3744 10 7.5 75 52 3,900 3744 4 26.5 106 2 212 3744 3 35 105 2 210 ........................ ........................ ........................ ........................ ........................ 8,972 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 Total hours PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[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]


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

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.

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

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 [email protected] 
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:

------------------------------------------------------------------------
                                                            OMB control
         21 CFR parts                    Topic                  No.
------------------------------------------------------------------------
1002, 1010, 1040.............  Reporting and                   0910-0025
                                Recordkeeping for
                                Electronic Products--
                                General Requirements.
------------------------------------------------------------------------



[[Page 20142]]

    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


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