Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Guidance for Industry and Food and Drug Administration Staff; Availability, 20143-20145 [2019-09380]
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<![CDATA[
20143
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
We base our estimate of the average
burden per response on our recent
experience with the existing
antimicrobial animal drug distribution
reports program. We base our estimate
of the number of affected respondents
reported in tables 1 and 2 and the
average number of responses per
respondent in table 1 on a review of our
records of sponsors with active and
inactive applications. We estimate that
20 sponsors will have active
applications, and we assume that half of
the respondents will report
electronically, while the other half will
report on paper. We estimate that 10
sponsors with active applications will
spend 62 hours annually to assemble
the necessary information, prepare, and
submit an annual antimicrobial animal
drug sales and distribution report on
paper, and 10 sponsors with active
applications will spend 52 hours
annually to assemble the necessary
information, prepare, and electronically
submit an annual antimicrobial animal
drug sales and distribution report. We
estimate that seven sponsors will have
inactive applications, and we assume
that half of these respondents will
report electronically, while the other
half will report on paper. We estimate
that sponsors with inactive applications
will spend 2 hours to prepare their
annual antimicrobial animal drug sales
and distribution reports, whether
electronically or on paper.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping required by section 512(l)(3) of the FD&C
Act ....................................................................................
27
1
27
2
54
khammond on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Animal drug manufacturers are
already required to maintain
distribution records for their animal
drug products to comply with FDA’s
current good manufacturing regulations
for periodic drug reports under
§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)),
approved under OMB control number
0910–0284. Section 512(l)(3) of the
FD&C Act differs from § 514.80(b)(4)(i)
in that it requires that records include
separate information for each month of
the calendar year. In addition, under 21
CFR 211.196 (approved under OMB
control number 0910–0139),
manufacturers currently are required to
maintain distribution records that
include dosage form and the date the
drug is distributed. Based on these
requirements, FDA believes that
manufacturers already keep detailed
records of the dates when antimicrobial
drugs are distributed for marketing and
recall purposes from which monthly
reports can be prepared as part of usual
and customary business practices.
However, FDA estimates an additional
recordkeeping burden of 54 hours for
further compliance with section
512(l)(3) of the FD&C Act, as detailed in
table 2.
Based on a review of the information
collection since our last request for
OMB approval, which was submitted
with a final rule, we have made no
adjustments to our burden estimates as
reported in tables 1 and 2, other than to
remove the one-time burden of 787
hours, which represented the time
needed to review the provisions of the
final rule and develop a compliance
plan in the first year of compliance.
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09425 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–2014–D–2245]
Classification and Requirements for
Laser Illuminated Projectors (Laser
Notice No. 57); 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 entitled ‘‘Classification and
Requirements for Laser Illuminated
Projectors (LIPs) (Laser Notice No. 57).’’
This guidance describes FDA’s policy
with respect to certain LIPs that comply
with International Electrotechnical
Commission (IEC) standards during
laser product classification under the
Electronic Product Radiation Control
provisions of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) that apply
to electronic products.
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
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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
E:\FR\FM\08MYN1.SGM
08MYN1
khammond on DSKBBV9HB2PROD with NOTICES
20144
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
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–
2014–D–2245 for ‘‘Classification and
Requirements for Laser Illuminated
Projectors (LIPs) (Laser Notice No. 57);
Guidance for Industry and Food and
Drug Administration Staff.’’ 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
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)).
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
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 ‘‘Classification and
Requirements for Laser Illuminated
Projectors (LIPs) (Laser Notice No. 57)’’
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 selfaddressed 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
This guidance describes FDA’s policy
with respect to certain LIPs that comply
with IEC standards during laser product
classification under the Electronic
Product Radiation Control provisions of
the FD&C Act (Pub. L. 90–602, amended
by Pub. L. 103–80) that apply to
electronic products. For purposes of this
guidance, the term ‘‘laser illuminated
projector’’ refers to a type of
demonstration laser product regulated
under 21 CFR 1040.10(b)(13) that is
designed to project a display image
without the use of raster-scanned
collimated laser beams. LIPs may be
used in locations such as indoor or
outdoor cinema theaters, laser shows,
presentations at conventions, image/
data projectors in office settings, or
homes. Under 21 CFR 1040.10(c), FDA
recognizes four major hazard classes
(I to IV) of lasers, including three
subclasses (IIa, IIIa, and IIIb). Under this
classification procedure higher laser
classes correspond to more powerful
lasers and a higher potential to pose
serious danger if used improperly.
As demonstration laser products, LIPs
and applications for LIPs cannot exceed
class IIIa emission limits as specified in
21 CFR 1040.11(c) (which is comparable
to IEC 60825–1 Ed. 3.0 Class 3R) unless
granted a variance by FDA under 21
CFR 1010.4. Some LIPs and applications
for LIPs will exceed the class IIIa limits
and therefore require a variance to
exceed those emission limits.
This guidance document describes
FDA’s intent to clarify the application of
certain aspects of the performance
standard requirements in 21 CFR
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
1040.11(c) for LIPs. Because the radiant
emission levels produced by LIPs can be
scientifically characterized by an
alternative IEC standard, IEC 62471–
5:Ed. 1.0, FDA does not intend to
enforce the requirements under 21 CFR
1040.10(c)(1) and 21 CFR 1040.11(c)
when LIP manufacturers conform to
these standards under the situations
outlined in sections III and IV of this
guidance.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of October 2, 2017
(82 FR 45861). FDA revised the
guidance as appropriate in response to
the comments. This guidance
supersedes ‘‘Immediately in Effect
Guidance Document: Classification and
Requirements for Laser Illuminated
Projectors (LIPs); Guidance for Industry
and Food and Drug Administration
Staff,’’ issued February 18, 2015.
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 classification and
requirements for LIPs (Laser Notice No.
57). 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 ‘‘Classification and Requirements for
Laser Illuminated Projectors (LIPs)
(Laser Notice No. 57)’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1400056 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
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
of information in the following FDA
regulations and forms have been
approved by OMB as listed in the
following table:
Topic
1002, 1010, 1040, and form FDA 3632 ...
Reporting and Recordkeeping for Electronic Products—General Requirements .......
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09380 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–2016–D–2049]
Medical X-Ray Imaging Devices
Conformance With International
Electrotechnical Commission
Standards; Guidance for Industry and
Food and Drug Administration Staff;
Availability
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 ‘‘Medical
X-Ray Imaging Devices Conformance
with IEC Standards.’’ This guidance
describes FDA’s policy regarding the
regulation of medical x-ray imaging
equipment that is subject to the Federal
Food, Drug and Cosmetic Act (FD&C
Act) and FDA’s regulations that apply to
medical devices and electronic
products.
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:
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
OMB control
No.
21 CFR part and form
AGENCY:
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,
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
20145
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–
2016–D–2049 for ‘‘Medical X-Ray
Imaging Devices Conformance with IEC
Standards.’’ 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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
0910–0025
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
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 ‘‘Medical X-Ray
Imaging Devices Conformance with IEC
Standards’’ 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:
Robert Sauer, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5628, Silver Spring,
MD 20993–0002, 301–796–3580.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20143-20145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09380]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2245]
Classification and Requirements for Laser Illuminated Projectors
(Laser Notice No. 57); 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 entitled ``Classification and
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No.
57).'' This guidance describes FDA's policy with respect to certain
LIPs that comply with International Electrotechnical Commission (IEC)
standards during laser product classification under the Electronic
Product Radiation Control provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) that apply to electronic products.
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
[[Page 20144]]
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-2014-D-2245 for ``Classification and Requirements for Laser
Illuminated Projectors (LIPs) (Laser Notice No. 57); Guidance for
Industry and Food and Drug Administration Staff.'' 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 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
``Classification and Requirements for Laser Illuminated Projectors
(LIPs) (Laser Notice No. 57)'' 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
This guidance describes FDA's policy with respect to certain LIPs
that comply with IEC standards during laser product classification
under the Electronic Product Radiation Control provisions of the FD&C
Act (Pub. L. 90-602, amended by Pub. L. 103-80) that apply to
electronic products. For purposes of this guidance, the term ``laser
illuminated projector'' refers to a type of demonstration laser product
regulated under 21 CFR 1040.10(b)(13) that is designed to project a
display image without the use of raster-scanned collimated laser beams.
LIPs may be used in locations such as indoor or outdoor cinema
theaters, laser shows, presentations at conventions, image/data
projectors in office settings, or homes. Under 21 CFR 1040.10(c), FDA
recognizes four major hazard classes (I to IV) of lasers, including
three subclasses (IIa, IIIa, and IIIb). Under this classification
procedure higher laser classes correspond to more powerful lasers and a
higher potential to pose serious danger if used improperly.
As demonstration laser products, LIPs and applications for LIPs
cannot exceed class IIIa emission limits as specified in 21 CFR
1040.11(c) (which is comparable to IEC 60825-1 Ed. 3.0 Class 3R) unless
granted a variance by FDA under 21 CFR 1010.4. Some LIPs and
applications for LIPs will exceed the class IIIa limits and therefore
require a variance to exceed those emission limits.
This guidance document describes FDA's intent to clarify the
application of certain aspects of the performance standard requirements
in 21 CFR 1040.11(c) for LIPs. Because the radiant emission levels
produced by LIPs can be scientifically characterized by an alternative
IEC standard, IEC 62471-5:Ed. 1.0, FDA does not intend to enforce the
requirements under 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c) when LIP
manufacturers conform to these standards under the situations outlined
in sections III and IV of this guidance.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of October 2, 2017 (82 FR 45861). FDA
revised the guidance as appropriate in response to the comments. This
guidance supersedes ``Immediately in Effect Guidance Document:
Classification and Requirements for Laser Illuminated Projectors
(LIPs); Guidance for Industry and Food and Drug Administration Staff,''
issued February 18, 2015.
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 classification and requirements for LIPs
(Laser Notice No. 57). 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 ``Classification and
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No.
57)'' may send an email request to [email protected] to receive
an electronic copy of the document. Please use the document number
1400056 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
[[Page 20145]]
of information in the following FDA regulations and forms have been
approved by OMB as listed in the following table:
------------------------------------------------------------------------
OMB control
21 CFR part and form Topic No.
------------------------------------------------------------------------
1002, 1010, 1040, and form FDA Reporting and 0910-0025
3632. Recordkeeping for
Electronic Products--
General Requirements.
------------------------------------------------------------------------
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09380 Filed 5-7-19; 8:45 am]
BILLING CODE 4164-01-P
