Policy Clarification for Certain Fluoroscopic Equipment Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability, 20146-20148 [2019-09406]
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20146
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
I. Background
This guidance describes FDA’s policy
regarding the regulation of medical xray imaging equipment that is subject to
the FD&C Act and FDA’s regulations
that apply to medical devices and
electronic products. In this guidance,
FDA is seeking to harmonize
performance standards prescribed
pursuant to section 534 of Subchapter C
(Electronic Product Radiation Control
(EPRC)) of the FD&C Act (21 U.S.C.
360(kk)) with International
Electrotechnical Commission (IEC)
standards, where appropriate, to help to
ensure streamlined regulatory review of
submissions for these products. The
guidance also provides
recommendations to industry on how to
comply with the applicable
requirements. FDA has determined that
industry conformance to certain IEC
standards would provide, at a
minimum, the same level of protection
of the public health and safety from
electronic radiation as certain EPRC
regulatory standards. In addition, due to
the recent publication of a proposed
rule (84 FR 12147) on April 1, 2019, that
would, if finalized, eliminate the
reporting requirements for x-ray imaging
devices, FDA determined that the
proposed policy outlined in section 4 of
the draft guidance, which stated that xray imaging devices that conform to IEC
standards would be considered to have
met the EPRC reporting requirements,
should be removed from the guidance.
This decision was made to avoid the
confusion inherent in establishing an
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 ‘‘Medical X-Ray
Imaging Devices Conformance with IEC
Standards.’’ 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.
Persons unable to download an
electronic copy of ‘‘Medical X-Ray
Imaging Devices Conformance with IEC
Standards’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 1400014 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
In the Federal Register of August 3,
2016 (81 FR 51201), we requested
comments on the revision of OMB
control number 0910–0025, ‘‘Reporting
and Recordkeeping for Electronic
Products—General Requirements,’’ to
adjust the annual reporting burden
consistent with the policy in the draft
guidance pertaining to reports.
However, because this final guidance
does not include this policy pertaining
to reports (see the Background section),
we have determined that the guidance
no longer necessitates revisions to OMB
control number 0910–0025.
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 part
Topic
807, subpart E ..........................................
800, 801, and 809 ....................................
820 ............................................................
1002 through 1050 ...................................
Premarket Notification ..................................................................................................
Medical Device Labeling Regulations ..........................................................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation .....
Reporting and Recordkeeping for Electronic Products—General Requirements .......
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09405 Filed 5–7–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1344]
BILLING CODE 4164–01–P
khammond on DSKBBV9HB2PROD with NOTICES
interim procedure that would shortly be
superseded by the final rule. However,
as stated in section V. of the guidance,
FDA believes that submission of a
declaration of conformity to the
appropriate standards, and model
identification as required by 21 CFR
1002.10(a) and (b), in a product report,
would be sufficient to meet the
requirements of a product report under
21 CFR 1002.10, thus reducing
duplication.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of August 3, 2016
(81 FR 51201). FDA revised the
guidance as appropriate in response to
the comments.
Policy Clarification for Certain
Fluoroscopic Equipment
Requirements; 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
SUMMARY:
VerDate Sep<11>2014
16:57 May 07, 2019
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PO 00000
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0910–0120
0910–0485
0910–0073
0910–0025
guidance entitled ‘‘Policy Clarification
for Certain Fluoroscopic Equipment
Requirements.’’ This guidance
document intends to clarify FDA’s
interpretation of certain aspects of the
performance standard requirements in
FDA’s regulations for fluoroscopic
equipment.
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:
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
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’’).
khammond on DSKBBV9HB2PROD with NOTICES
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–
2014–D–1344 for ‘‘Policy Clarification
for Certain Fluoroscopic Equipment
Requirements.’’ 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
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
‘‘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)).
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 ‘‘Policy Clarification
for Certain Fluoroscopic Equipment
Requirements’’ 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:
Donald Miller, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4318, Silver Spring,
MD 20993–0002, 301–796–3299.
SUPPLEMENTARY INFORMATION:
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I. Background
This guidance document intends to
clarify FDA’s interpretation of certain
aspects of the performance standard
requirements in §§ 1020.30 and 1020.32
(21 CFR 1020.30 and 1020.32) for
fluoroscopic equipment. Specifically, it
clarifies FDA’s interpretation of
fluoroscopic irradiation time
(§ 1020.30(b)), the permissible duration
of the activation of the x-ray tube in the
fluoroscopic mode (§ 1020.32(c)), and
on inclusion of an emergency
fluoroscopy mode in fluoroscopes.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of September 25,
2014 (79 FR 57559). 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 ‘‘Policy Clarification
for Certain Fluoroscopic Equipment
Requirements.’’ 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 ‘‘Policy Clarification for Certain
Fluoroscopic Equipment Requirements’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document 1806 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:
E:\FR\FM\08MYN1.SGM
08MYN1
20148
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
Topic
807, subpart E ..........................................
1020 ..........................................................
Premarket Notification ..................................................................................................
Reporting and Recordkeeping for Electronic Products—General Requirements .......
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09406 Filed 5–7–19; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2018–N–3138]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of an Accelerated Approval
Disclosure
AGENCY:
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by June 7,
2019.
DATES:
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–NEW and
title ‘‘Experimental Study of an
Accelerated Approval Disclosure.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:57 May 07, 2019
collection of information to OMB for
review and clearance.
Experimental Study of an Accelerated
Approval Disclosure
OMB Control Number 0910–NEW
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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OMB control
No.
21 CFR part
Jkt 247001
I. Background
Section 1701(a)(4) of the Public
Health Service Act (PHS Act) (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)) authorizes
FDA to conduct research relating to
drugs and other FDA-regulated products
in carrying out the provisions of the
FD&C Act.
The mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
to ensure that prescription drug
information is truthful, balanced, and
accurately communicated so that
patients and healthcare providers can
make informed decisions about
treatment options. The OPDP’s research
program supports this mission by
providing scientific evidence to help
ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that we believe are most central to our
mission, focusing in particular on three
main topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and disease and
product characteristics impact the
communication and understanding of
prescription drug risks and benefits;
focusing on target populations allows us
to evaluate how understanding of
prescription drug risks and benefits may
vary as a function of audience; and our
focus on research quality aims at
maximizing the quality of research data
through analytical methodology
development and investigation of
sampling and response issues. This
study falls under the topic of advertising
features (content and format).
Pursuant to section 506(c) of the
FD&C Act (21 U.S.C. 356(c)) and 21 CFR
part 314, subpart H (or 21 CFR part 601,
subpart E for biological products), FDA
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0910–0120
0910–0025
may grant accelerated approval to a drug
product under section 505(c) of the
FD&C Act (21 U.S.C. 355(c)) or a
biological product under section 351(a)
of the PHS Act (42 U.S.C 262(a)). This
pathway enables faster approval of
prescription drugs intended to treat
serious or life-threatening illnesses.
Accelerated approval may be based on
a determination that a drug product has
an effect on a surrogate endpoint (for
example, a blood test result) that is
reasonably likely to predict clinical
benefit, or on a clinical endpoint that
can be measured earlier than
irreversible morbidity or mortality, that
is reasonably likely to predict an effect
on irreversible morbidity or mortality or
other clinical benefit (i.e., an
intermediate clinical endpoint). In
approving a drug under the accelerated
approval pathway, the severity, rarity,
or prevalence of a condition, and the
availability or lack of alternative
treatments, are taken into account.
The accelerated approval pathway is
limited to certain products intended to
treat serious or life-threatening illnesses
as there can be ‘‘[u]ncertainty about
whether clinical benefit will be verified
and the possibility of undiscovered
risks’’ (FDA 2014 guidance for industry
entitled ‘‘Expedited Programs for
Serious Conditions—Drugs and
Biologics,’’ available at https://
www.fda.gov/files/drugs/published/
Expedited-Programs-for-SeriousConditions-Drugs-and-Biologics.pdf).
Sponsors are generally required to
conduct post approval studies to verify
and describe the predicted clinical
benefit, but those confirmatory studies
are not complete at the time that the
accelerated approval is granted (Ref. 1).
In the event that the required post
approval confirmatory studies fail to
verify and describe the predicted effect
or clinical benefit, a drug’s approval can
be withdrawn using expedited
procedures.
Under FDA’s regulations governing
physician labeling for prescription
drugs, the INDICATIONS AND USAGE
section of the FDA-approved prescribing
information (PI) for a drug approved
under accelerated approval must
include a succinct description of the
limitations of usefulness of the drug and
any uncertainty about anticipated
clinical benefits, with reference to the
clinical studies section for a discussion
of the available evidence (21 CFR
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]]>Agencies
[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20146-20148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09406]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1344]
Policy Clarification for Certain Fluoroscopic Equipment
Requirements; 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 ``Policy Clarification
for Certain Fluoroscopic Equipment Requirements.'' This guidance
document intends to clarify FDA's interpretation of certain aspects of
the performance standard requirements in FDA's regulations for
fluoroscopic equipment.
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:
[[Page 20147]]
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-2014-D-1344 for ``Policy Clarification for Certain Fluoroscopic
Equipment Requirements.'' 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
``Policy Clarification for Certain Fluoroscopic Equipment
Requirements'' 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: Donald Miller, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4318, Silver Spring, MD 20993-0002, 301-796-3299.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document intends to clarify FDA's interpretation of
certain aspects of the performance standard requirements in Sec. Sec.
1020.30 and 1020.32 (21 CFR 1020.30 and 1020.32) for fluoroscopic
equipment. Specifically, it clarifies FDA's interpretation of
fluoroscopic irradiation time (Sec. 1020.30(b)), the permissible
duration of the activation of the x-ray tube in the fluoroscopic mode
(Sec. 1020.32(c)), and on inclusion of an emergency fluoroscopy mode
in fluoroscopes.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of September 25, 2014 (79 FR 57559).
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 ``Policy Clarification for Certain
Fluoroscopic Equipment Requirements.'' 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 ``Policy Clarification
for Certain Fluoroscopic Equipment Requirements'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document 1806 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:
[[Page 20148]]
------------------------------------------------------------------------
OMB control
21 CFR part Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket Notification. 0910-0120
1020........................... Reporting and 0910-0025
Recordkeeping for
Electronic Products--
General Requirements.
------------------------------------------------------------------------
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09406 Filed 5-7-19; 8:45 am]
BILLING CODE 4164-01-P
