Laser Products-Conformance With IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 2789-2790 [2018-00898]

Download as PDF Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices the scope of an approved BLA. 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. II. Paperwork Reduction Act of 1995 This guidance contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501– 3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of January 13, 2017, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (82 FR 4358 at 4359). The information collection provisions in this guidance will be submitted to OMB for review as required by section 3507(d) of the PRA. These provisions are not in effect until they display a currently valid OMB control number. FDA will publish a notice in the Federal Register announcing OMB’s decision regarding the information collection provisions in this guidance. The guidance also references registration and adverse event reporting for outsourcing facilities. The collections of information for outsourcing facility registration have been approved by OMB under OMB control number 0910–0777. The collections of information for adverse event reporting by outsourcing facilities have been approved by OMB under OMB control number 0910–0800. daltland on DSKBBV9HB2PROD with NOTICES III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https:// www.regulations.gov. VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–00916 Filed 1–18–18; 8:45 am] BILLING CODE 4164–01–P 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); Draft 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 the draft guidance entitled ‘‘Conformance with IEC 60825–1 Ed. 3 and IEC 60601–2–22 Ed. 3.1 (Laser Notice No. 56).’’ This draft guidance describes the Agency’s proposed 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, FDA does not intend to consider whether firms that comply with the comparable IEC standards discussed in this guidance document also comply with performance standards in FDA’s regulations. 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 March 20, 2018 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: SUMMARY: 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 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 2789 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 ‘‘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 both copies to the Dockets Management Staff. If you do not wish your name and E:\FR\FM\19JAN1.SGM 19JAN1 2790 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 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 10115(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 ‘‘Conformance with IEC 60825–1 Ed. 3 and IEC 60601–2–22 Ed.3.1 (Laser Notice No. 56)’’ 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: daltland on DSKBBV9HB2PROD with NOTICES 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. VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 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. 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/ downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm094366.pdf). This draft guidance, when finalized, will not replace the recommendations provided in that 2007 guidance, and upon finalization of this guidance, manufacturers can follow either Laser Notice No. 50 or this guidance. 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 ‘‘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 draft guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH 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 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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 draft 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 1002.10, 1010.2, 1010.3, 1040.10, and 1040.11 have been approved under OMB control number 0910–0025. Dated: January 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–00898 Filed 1–18–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1309] Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; 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 guidance for industry entitled ‘‘Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ One of the conditions to qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is that a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms ‘‘commercially available,’’ ‘‘essentially a copy of a commercially available drug SUMMARY: E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2789-2790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00898]


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

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); 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 ``Conformance with IEC 
60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' This 
draft guidance describes the Agency's proposed 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, FDA does not intend to consider whether firms 
that comply with the comparable IEC standards discussed in this 
guidance document also comply with performance standards in FDA's 
regulations. 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 March 20, 2018 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 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 ``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 both copies to the Dockets Management Staff. If you do not wish 
your name and

[[Page 2790]]

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 
10115(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 
``Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed.3.1 (Laser 
Notice No. 56)'' 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

    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.  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.  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.
    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/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094366.pdf). This 
draft guidance, when finalized, will not replace the recommendations 
provided in that 2007 guidance, and upon finalization of this guidance, 
manufacturers can follow either Laser Notice No. 50 or this guidance.

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 ``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 draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all CDRH 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 draft 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 1002.10, 1010.2, 1010.3, 1040.10, 
and 1040.11 have been approved under OMB control number 0910-0025.

    Dated: January 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00898 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P

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