83 FR 2789 - Laser Products-Conformance With IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2789-2790 | |
| FR Document | 2018-00898 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2789-2790] From the Federal Register Online [www.thefederalregister.org] [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FDA-2017-D-7011] Laser Products--Conformance With IEC 60825-1 Ed. 3 and IEC 60601- 2-22 Ed. 3.1 (Laser Notice No. 56); Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' This draft guidance describes the Agency's proposed approach regarding compliance with FDA's performance standards for laser products.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 This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2789
the scope of an approved BLA. It does Dated: January 16, 2018. solely responsible for ensuring that your
not establish any rights for any person Leslie Kux, comment does not include any
and is not binding on FDA or the public. Associate Commissioner for Policy. confidential information that you or a
You can use an alternative approach if [FR Doc. 2018–00916 Filed 1–18–18; 8:45 am] third party may not wish to be posted,
it satisfies the requirements of the BILLING CODE 4164–01–P such as medical information, your or
applicable statutes and regulations. anyone else’s Social Security number, or
confidential business information, such
II. Paperwork Reduction Act of 1995 as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND
This guidance contains collections of HUMAN SERVICES that if you include your name, contact
information that are subject to review by information, or other information that
the Office of Management and Budget Food and Drug Administration identifies you in the body of your
(OMB) under the Paperwork Reduction [Docket No. FDA–2017–D–7011] comments, that information will be
Act (PRA) of 1995 (44 U.S.C. 3501– posted on https://www.regulations.gov.
3520). Under the PRA, Federal Agencies Laser Products—Conformance With • If you want to submit a comment
must obtain approval from OMB for IEC 60825–1 Ed. 3 and IEC 60601–2–22 with confidential information that you
each collection of information they Ed. 3.1 (Laser Notice No. 56); Draft do not wish to be made available to the
conduct or sponsor. ‘‘Collection of Guidance for Industry and Food and public, submit the comment as a
information’’ is defined in 44 U.S.C. Drug Administration Staff; Availability written/paper submission and in the
3502(3) and 5 CFR 1320.3 and includes manner detailed (see ‘‘Written/Paper
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
Agency requests or requirements that
HHS.
members of the public submit reports, Written/Paper Submissions
keep records, or provide information to ACTION: Notice of availability.
Submit written/paper submissions as
a third party. Section 3506(c)(2)(A) of SUMMARY: The Food and Drug follows:
the PRA (44 U.S.C. 3506(c)(2)(A)) Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
requires Federal Agencies to provide a announcing the availability of the draft written/paper submissions): Dockets
60-day notice in the Federal Register guidance entitled ‘‘Conformance with Management Staff (HFA–305), Food and
concerning each proposed collection of IEC 60825–1 Ed. 3 and IEC 60601–2–22 Drug Administration, 5630 Fishers
information before submitting the Ed. 3.1 (Laser Notice No. 56).’’ This Lane, Rm. 1061, Rockville, MD 20852.
collection to OMB for approval. To draft guidance describes the Agency’s • For written/paper comments
comply with this requirement, in the proposed approach regarding submitted to the Dockets Management
Federal Register of January 13, 2017, we compliance with FDA’s performance Staff, FDA will post your comment, as
gave interested persons 60 days to standards for laser products. FDA well as any attachments, except for
comment on the information collection believes that under the circumstances information submitted, marked and
provisions in the draft guidance (82 FR described in this guidance, conformance identified, as confidential, if submitted
4358 at 4359). with certain International as detailed in ‘‘Instructions.’’
The information collection provisions Electrotechnical Commission (IEC) Instructions: All submissions received
in this guidance will be submitted to standards would provide adequate must include the Docket No. FDA–
OMB for review as required by section protection of the public health and 2017–D–7011 for ‘‘Conformance with
3507(d) of the PRA. These provisions safety for laser products similar to IEC 60825–1 Ed. 3 and IEC 60601–2–22
are not in effect until they display a performance standards in FDA’s Ed.3.1 (Laser Notice No. 56).’’ Received
currently valid OMB control number. regulations. Accordingly, FDA does not comments will be placed in the docket
FDA will publish a notice in the Federal intend to consider whether firms that and, except for those submitted as
Register announcing OMB’s decision comply with the comparable IEC ‘‘Confidential Submissions,’’ publicly
regarding the information collection standards discussed in this guidance viewable at https://www.regulations.gov
provisions in this guidance. document also comply with or at the Dockets Management Staff
The guidance also references performance standards in FDA’s between 9 a.m. and 4 p.m., Monday
registration and adverse event reporting regulations. This draft guidance is not through Friday.
for outsourcing facilities. The final nor is it in effect at this time. • Confidential Submissions—To
collections of information for DATES: Submit either electronic or submit a comment with confidential
outsourcing facility registration have written comments on the draft guidance information that you do not wish to be
been approved by OMB under OMB by March 20, 2018 to ensure that the made publicly available, submit your
control number 0910–0777. The Agency considers your comment on this comments only as a written/paper
collections of information for adverse draft guidance before it begins work on submission. You should submit two
event reporting by outsourcing facilities the final version of the guidance. copies total. One copy will include the
have been approved by OMB under ADDRESSES: You may submit comments information you claim to be confidential
OMB control number 0910–0800. on any guidance at any time as follows: with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
III. Electronic Access Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Persons with access to the internet Submit electronic comments in the Agency will review this copy, including
may obtain the guidance at either following way: the claimed confidential information, in
https://www.fda.gov/Drugs/ • Federal eRulemaking Portal: its consideration of comments. The
daltland on DSKBBV9HB2PROD with NOTICES
GuidanceComplianceRegulatory https://www.regulations.gov. Follow the second copy, which will have the
Information/Guidances/default.htm, instructions for submitting comments. claimed confidential information
https://www.fda.gov/Biologics Comments submitted electronically, redacted/blacked out, will be available
BloodVaccines/GuidanceCompliance including attachments, to https:// for public viewing and posted on
RegulatoryInformation/Guidances/ www.regulations.gov will be posted to https://www.regulations.gov. Submit
default.htm, or https:// the docket unchanged. Because your both copies to the Dockets Management
www.regulations.gov. comment will be made public, you are Staff. If you do not wish your name and
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![2790 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
contact information to be made publicly Complying with FDA regulations and IEC 60825–1 Ed. 3 and IEC 60601–2–22
available, you can provide this conforming to the identified IEC Ed.3.1 (Laser Notice No. 56)’’ may send
information on the cover sheet and not standards may cause manufacturers to an email request to CDRH-Guidance@
in the body of your comments and you duplicate their efforts. fda.hhs.gov to receive an electronic
must identify this information as FDA acknowledges the advantages of copy of the document. Please use the
‘‘confidential.’’ Any information marked a universal set of device-specific criteria document number 1500024 to identify
as ‘‘confidential’’ will not be disclosed and requirements. Moreover, FDA the guidance you are requesting.
except in accordance with 21 CFR 10.20 believes that under the circumstances
described in this guidance, conformance IV. Paperwork Reduction Act of 1995
and other applicable disclosure law. For
more information about FDA’s posting with certain IEC standards would This draft guidance refers to
of comments to public dockets, see 80 provide adequate protection of the previously approved collections of
FR 56469, September 18, 2015, or access public health and safety for laser information found in FDA regulations.
the information at: https://www.gpo.gov/ products similar to FDA’s performance These collections of information are
fdsys/pkg/FR-2015-09-18/pdf/2015- standards in §§ 1040.10 and 1040.11 (21 subject to review by the Office of
23389.pdf. CFR 1040.10 and 1040.11). FDA Management and Budget (OMB) under
Docket: For access to the docket to eventually intends to amend its the Paperwork Reduction Act of 1995
read background documents or the standards for laser products at (44 U.S.C. 3501–3520). The collections
electronic and written/paper comments §§ 1040.10 and 1040.11 to harmonize of information in 21 CFR 1002.10,
received, go to https:// many of its requirements with those of 1010.2, 1010.3, 1040.10, and 1040.11
www.regulations.gov and insert the the IEC because FDA acknowledges the have been approved under OMB control
docket number, found in brackets in the advantages of one set of criteria and number 0910–0025.
heading of this document, into the requirements worldwide.
Dated: January 12, 2018.
‘‘Search’’ box and follow the prompts On June 24, 2007, FDA’s Center for
Devices and Radiological Health (CDRH) Leslie Kux,
and/or go to the Dockets Management
published a guidance entitled ‘‘Laser Associate Commissioner for Policy.
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Products—Conformance with IEC [FR Doc. 2018–00898 Filed 1–18–18; 8:45 am]
You may submit comments on any 60825–1 and IEC 60601–2–22; Guidance BILLING CODE 4164–01–P
guidance at any time (see 21 CFR for Industry and FDA Staff (Laser Notice
10115(g)(5)). No. 50)’’ (https://www.fda.gov/
An electronic copy of the guidance downloads/MedicalDevices/ DEPARTMENT OF HEALTH AND
document is available for download DeviceRegulationandGuidance/ HUMAN SERVICES
from the internet. See the GuidanceDocuments/ucm094366.pdf).
This draft guidance, when finalized, Food and Drug Administration
SUPPLEMENTARY INFORMATION section for
information on electronic access to the will not replace the recommendations [Docket No. FDA–2016–D–1309]
guidance. Submit written requests for a provided in that 2007 guidance, and
single hard copy of the draft guidance upon finalization of this guidance, Compounded Drug Products That Are
document entitled ‘‘Conformance with manufacturers can follow either Laser Essentially Copies of a Commercially
IEC 60825–1 Ed. 3 and IEC 60601–2–22 Notice No. 50 or this guidance. Available Drug Product Under Section
Ed.3.1 (Laser Notice No. 56)’’ to the II. Significance of Guidance 503A of the Federal Food, Drug, and
Office of the Center Director, Guidance Cosmetic Act; Guidance for Industry;
This draft guidance is being issued Availability
and Policy Development, Center for
consistent with FDA’s good guidance
Devices and Radiological Health, Food AGENCY: Food and Drug Administration,
practices regulation (21 CFR 10.115).
and Drug Administration, 10903 New HHS.
The draft guidance, when finalized, will
Hampshire Ave., Bldg. 66, Rm. 5431,
represent the current thinking of FDA ACTION: Notice of availability.
Silver Spring, MD 20993–0002. Send
on ‘‘Laser Products—Conformance with
one self-addressed adhesive label to SUMMARY: The Food and Drug
IEC 60825–1 Ed. 3 and IEC 60601–2–22
assist that office in processing your Administration (FDA or Agency) is
Ed.3.1 (Laser Notice No. 56)’’. It does
request. announcing the availability of a
not establish any rights for any person
FOR FURTHER INFORMATION CONTACT: and is not binding on FDA or the public. guidance for industry entitled
Patrick Hintz, Center for Devices and You can use an alternative approach if ‘‘Compounded Drug Products That Are
Radiological Health, Food and Drug it satisfies the requirements of the Essentially Copies of a Commercially
Administration, 10903 New Hampshire applicable statutes and regulations. This Available Drug Product Under Section
Ave., Bldg. 66, Rm. 4228, Silver Spring, guidance is not subject to Executive 503A of the Federal Food, Drug, and
MD 20993–0002, 301–796–6927. Order 12866. Cosmetic Act.’’ One of the conditions to
SUPPLEMENTARY INFORMATION: qualify for exemptions under section
III. Electronic Access 503A of the Federal Food, Drug, and
I. Background Persons interested in obtaining a copy Cosmetic Act (the FD&C Act), is that a
FDA recognizes that the IEC is a of the draft guidance may do so by drug product must be compounded by
global organization that prepares and downloading an electronic copy from a licensed pharmacist or physician who
publishes international standards for the internet. A search capability for all does not compound regularly or in
electrical, electronic, and related CDRH guidance documents is available inordinate amounts any drug products
daltland on DSKBBV9HB2PROD with NOTICES
technologies, including laser products. at https://www.fda.gov/MedicalDevices/ that are essentially copies of a
This means that manufacturers DeviceRegulationandGuidance/ commercially available drug product.
distributing products in the United GuidanceDocuments/default.htm. This This guidance sets forth FDA policies
States and other countries might have to guidance document is also available at regarding this provision of section
ensure conformance of their products https://www.regulations.gov. Persons 503A, including the terms
with IEC standards as well as comply unable to download an electronic copy ‘‘commercially available,’’ ‘‘essentially a
with FDA regulatory requirements. of ‘‘Laser Products—Conformance with copy of a commercially available drug
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Document Created: 2018-01-19 02:42:59
Document Modified: 2018-01-19 02:42:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 2789 |
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