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]
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<![CDATA[
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
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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
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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
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]]>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.
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[[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
