Enforcement Policy for Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability, 72080-72082 [2023-23110]
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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
2. Activity-Based Stock Purchase
Requirement Submissions
FHFA estimates that the average
number of daily transactions between
Banks and members that will require the
exchange of information to confirm the
member’s activity-based stock purchase
requirement will be 300, and that there
will be an average of 261 working days
per year, resulting in an estimated
78,300 submissions annually. The
estimate for the average preparation
time per submission is 0.2 hours.
Accordingly, the estimate for the annual
hour burden associated with activitybased stock purchase requirement
submissions is (78,300 submissions ×
0.2 hours per submission) = 15,660
hours.
E. Comment Request
In accordance with the requirements
of 5 CFR 1320.8(d), FHFA published an
initial notice and request for public
comments regarding this information
collection in the Federal Register on
August 8, 2023.4 The 60-day comment
period closed on October 10, 2023.
FHFA received no substantive
comments.
FHFA requests written comments on
the following: (1) whether the collection
of information is necessary for the
proper performance of FHFA functions,
including whether the information has
practical utility; (2) the accuracy of
FHFA’s estimates of the burdens of the
collection of information; (3) ways to
enhance the quality, utility, and clarity
of the information collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Shawn Bucholtz,
Chief Data Officer, Federal Housing Finance
Agency.
[FR Doc. 2023–23067 Filed 10–18–23; 8:45 am]
BILLING CODE 8070–01–P
FEDERAL RESERVE SYSTEM
Sunshine Meeting Notice
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 1:00 p.m. on Wednesday,
October 25, 2023.
PLACE: Martin Federal Reserve Board
Building, C Street entrance between
20th and 21st Streets NW, Washington,
DC 20551.
STATUS: Open.
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AGENCY HOLDING THE MEETING:
4 See
88 FR 53484 (Aug. 8, 2023).
VerDate Sep<11>2014
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On the day of the meeting, you will
be able to view the meeting via webcast
from a link available on the Board’s
website. You do not need to register to
view the webcast of the meeting. A link
to the meeting documentation will also
be available approximately 20 minutes
before the start of the meeting. Both
links may be accessed from the Board’s
website at www.federalreserve.gov.
If you plan to attend the open meeting
in person, we ask that you notify us in
advance and provide your name, date of
birth, and social security number (SSN)
or passport number. You may provide
this information by calling 202–452–
2474 or you may register online
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October 24, 2023. You also will be asked
to provide identifying information,
including a photo ID, before being
admitted to the Board meeting. The
Public Affairs Office must approve the
use of cameras; please email media@
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for any false statements you make in
your request to enter the Board’s
premises.
PO 00000
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MATTERS TO BE CONSIDERED:
Discussion Agenda
1. Proposed revisions to the Board’s
debit interchange fee cap.
Notes: 1. For those attending in
person, the staff memo will be available
to attendees on the day of the meeting
in paper. Meeting documentation will
be available on the Board’s website
about 20 minutes before the start of the
meeting.
2. This meeting will be recorded for
the benefit of those unable to attend.
The webcast recording and a transcript
of the meeting will be available after the
meeting on the Board’s website https://
www.federalreserve.gov/aboutthefed/
boardmeetings/.
For questions please contact: Public
Affairs Office at media@frb.gov.
SUPPLEMENTARY INFORMATION: You may
access the Board’s website at
www.federalreserve.gov for an electronic
announcement. (The website also
includes procedural and other
information about the open meeting.)
Dated: October 16, 2023.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2023–23116 Filed 10–18–23; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4356]
Enforcement Policy for Non-Invasive
Remote Monitoring Devices Used To
Support Patient Monitoring; 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 ‘‘Enforcement Policy
for Non-Invasive Remote Monitoring
Devices Used to Support Patient
Monitoring.’’ The enforcement policy
described in this guidance applies to
modified devices where the original
device was a legally marketed, noninvasive remote monitoring device
listed in the guidance that measures or
detects common physiological
parameters and that is used to support
patient monitoring. The guidance is
intended to describe the enforcement
policy for limited modifications to the
indications, functionality, or hardware
SUMMARY:
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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
or software of device types in the scope
of the guidance without prior
submission of a 510(k) where such
submission would be required.
DATES: The announcement of the
guidance is published in the Federal
Register on October 19, 2023.
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’’).
lotter on DSK11XQN23PROD with NOTICES1
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–
2023–D–4356 for ‘‘Enforcement Policy
for Non-Invasive Remote Monitoring
Devices Used to Support Patient
Monitoring.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
VerDate Sep<11>2014
17:48 Oct 18, 2023
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https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 ‘‘Enforcement Policy
for Non-Invasive Remote Monitoring
Devices Used to Support Patient
Monitoring’’ to the Office of Policy,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
PO 00000
Frm 00041
Fmt 4703
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72081
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Jessica Paulsen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2108, Silver Spring,
MD 20993–0002, 301–796–6883.
SUPPLEMENTARY INFORMATION:
I. Background
The enforcement policy described in
this guidance applies to modified
devices where the original device was a
legally marketed, noninvasive remote
monitoring device listed in the guidance
that measures or detects common
physiological parameters and that is
used to support patient monitoring. The
guidance is intended to describe the
enforcement policy for limited
modifications to the indications,
functionality, or hardware or software of
device types in the scope of the
guidance without prior submission of a
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) (see 21 CFR 807.81) where such
submission would be required. This
guidance supersedes ‘‘Enforcement
Policy for Non-Invasive Remote
Monitoring Devices Used to Support
Patient Monitoring During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency’’ issued in
March 2020 and updated in June 2020,
October 2020, and March 2023.
In the Federal Register of March 13,
2023 (88 FR 15417), FDA announced
that that guidance was being revised to
continue in effect for 180 days after the
expiration of the COVID–19 public
health emergency (PHE) declaration
issued under section 319 of the Public
Health Service Act, during which time,
FDA intended to further revise the
guidance. Consistent with what we said
in the Federal Register of March 13,
2023, FDA is therefore issuing this
revised final guidance.
Leveraging the perspective gained
during the COVID–19 pandemic, FDA is
updating the policy reflected in the
‘‘Enforcement Policy for Non-Invasive
Remote Monitoring Devices Used to
Support Patient Monitoring During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency’’ guidance to
exercise certain enforcement policies for
certain devices beyond the expiration of
the COVID–19 PHE (which expired on
May 11, 2023) and the 180-day period
announced in the March 13, 2023
Federal Register notice, including by
removing clinical thermometers and
pulse oximeters from the scope of the
guidance, revising the policy with
E:\FR\FM\19OCN1.SGM
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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
respect to certain device types subject to
special controls, and removing use of
the term ‘‘claims.’’
This guidance is being implemented
without prior public comment because
FDA has determined that prior public
participation for this guidance is not
feasible or appropriate (see section
701(h)(1)(C) of the FD&C Act (21 U.S.C.
371(h)(1)(C)) and § 10.115(g)(2) (21 CFR
10.115(g)(2)). FDA has determined that
this guidance document presents a less
burdensome policy that is consistent
with public health. Although this policy
is being implemented immediately
without prior comment, it remains
subject to comment in accordance with
FDA’s good guidance practices
regulation (§ 10.115(g)(3)(i)(D)). FDA
will consider all comments received and
revise the guidance document as
appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the current thinking
II. 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/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Enforcement Policy
for Non-Invasive Remote Monitoring
Devices Used to Support Patient
Monitoring’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number GUI00007017 and complete
title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
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–
3521). The collections of information in
the following FDA regulations,
guidance, and forms 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 ......................................................................
Premarket Notification ................................................................
Medical Device Labeling Regulations ........................................
Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of eight
abbreviated new drug applications
(ANDAs) from multiple applicants. The
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4414]
Approval is withdrawn as of
November 20, 2023.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
DATES:
American Regent, Inc., et al.;
Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY:
Notice.
SUMMARY:
[FR Doc. 2023–23110 Filed 10–18–23; 8:45 am]
Food and Drug Administration,
HHS.
0910–0120
0910–0485
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived the
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 040515 ....................................................
Promethazine Hydrochloride Injectable, 25
milligrams (mg)/milliliter (mL).
Sulfacetamide Sodium Solution/Drops, 10%
and 30%.
Riluzole Tablet, 50 mg .....................................
American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
Allergan Sales, LLC, 2525 Dupont Dr., Irvine,
CA 92612.
Apotex Corp., U.S. Agent for Apotex Inc.,
2400 North Commerce Parkway, Suite 400,
Weston, FL 33326.
Lachman Consultant Services, Inc., U.S.
Agent for Aspen Global Inc., 1600 Stewart
Ave., Suite 604, Westbury, NY 11590.
Apotex Corp., U.S. Agent for Apotex Inc.
ANDA 080028 ....................................................
ANDA 091300 ....................................................
lotter on DSK11XQN23PROD with NOTICES1
of FDA on ‘‘Enforcement Policy for NonInvasive Remote Monitoring Devices
Used to Support Patient Monitoring.’’ 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.
ANDA 200271 ....................................................
Hydroxyprogesterone
Caproate
1,250 mg/5 mL (250 mg/mL).
ANDA 201570 ....................................................
Abacavir Sulfate Tablet, Equivalent to (EQ)
300 mg base.
VerDate Sep<11>2014
17:48 Oct 18, 2023
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Solution,
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19OCN1
]]>Agencies
[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72080-72082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23110]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4356]
Enforcement Policy for Non-Invasive Remote Monitoring Devices
Used To Support Patient Monitoring; 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 ``Enforcement Policy for
Non-Invasive Remote Monitoring Devices Used to Support Patient
Monitoring.'' The enforcement policy described in this guidance applies
to modified devices where the original device was a legally marketed,
non-invasive remote monitoring device listed in the guidance that
measures or detects common physiological parameters and that is used to
support patient monitoring. The guidance is intended to describe the
enforcement policy for limited modifications to the indications,
functionality, or hardware
[[Page 72081]]
or software of device types in the scope of the guidance without prior
submission of a 510(k) where such submission would be required.
DATES: The announcement of the guidance is published in the Federal
Register on October 19, 2023.
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-2023-D-4356 for ``Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient Monitoring.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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
``Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to
Support Patient Monitoring'' to the Office of Policy, 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: Jessica Paulsen, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2108, Silver Spring, MD 20993-0002, 301-
796-6883.
SUPPLEMENTARY INFORMATION:
I. Background
The enforcement policy described in this guidance applies to
modified devices where the original device was a legally marketed,
noninvasive remote monitoring device listed in the guidance that
measures or detects common physiological parameters and that is used to
support patient monitoring. The guidance is intended to describe the
enforcement policy for limited modifications to the indications,
functionality, or hardware or software of device types in the scope of
the guidance without prior submission of a premarket notification under
section 510(k) of the FD&C Act (21 U.S.C. 360(k)) (see 21 CFR 807.81)
where such submission would be required. This guidance supersedes
``Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to
Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-
19) Public Health Emergency'' issued in March 2020 and updated in June
2020, October 2020, and March 2023.
In the Federal Register of March 13, 2023 (88 FR 15417), FDA
announced that that guidance was being revised to continue in effect
for 180 days after the expiration of the COVID-19 public health
emergency (PHE) declaration issued under section 319 of the Public
Health Service Act, during which time, FDA intended to further revise
the guidance. Consistent with what we said in the Federal Register of
March 13, 2023, FDA is therefore issuing this revised final guidance.
Leveraging the perspective gained during the COVID-19 pandemic, FDA
is updating the policy reflected in the ``Enforcement Policy for Non-
Invasive Remote Monitoring Devices Used to Support Patient Monitoring
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency'' guidance to exercise certain enforcement policies for
certain devices beyond the expiration of the COVID-19 PHE (which
expired on May 11, 2023) and the 180-day period announced in the March
13, 2023 Federal Register notice, including by removing clinical
thermometers and pulse oximeters from the scope of the guidance,
revising the policy with
[[Page 72082]]
respect to certain device types subject to special controls, and
removing use of the term ``claims.''
This guidance is being implemented without prior public comment
because FDA has determined that prior public participation for this
guidance is not feasible or appropriate (see section 701(h)(1)(C) of
the FD&C Act (21 U.S.C. 371(h)(1)(C)) and Sec. 10.115(g)(2) (21 CFR
10.115(g)(2)). FDA has determined that this guidance document presents
a less burdensome policy that is consistent with public health.
Although this policy is being implemented immediately without prior
comment, it remains subject to comment in accordance with FDA's good
guidance practices regulation (Sec. 10.115(g)(3)(i)(D)). FDA will
consider all comments received and revise the guidance document as
appropriate.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on ``Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient Monitoring.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Enforcement Policy for Non-Invasive
Remote Monitoring Devices Used to Support Patient Monitoring'' may send
an email request to [email protected] to receive an electronic
copy of the document. Please use the document number GUI00007017 and
complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved 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. 3501-3521). The collections of information in
the following FDA regulations, guidance, and forms have been approved
by OMB as listed in the following table:
------------------------------------------------------------------------
OMB control
21 CFR Part Topic No.
------------------------------------------------------------------------
807, subpart E.................... Premarket 0910-0120
Notification.
800, 801, and 809................. Medical Device 0910-0485
Labeling
Regulations.
------------------------------------------------------------------------
Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23110 Filed 10-18-23; 8:45 am]
BILLING CODE 4164-01-P
