Notice2023-23110
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
October 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 or software of device types in the scope of the guidance without prior submission of a 510(k) where such submission would be required.
Full Text
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<title>Federal Register, Volume 88 Issue 201 (Thursday, October 19, 2023)</title>
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[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72080-72082]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23110]
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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.
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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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#baf9fee8f297fdcfd3dedbd4d9dffadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="92d1d6c0dabfd5e7fbf6f3fcf1f7d2f4f6f3bcfafae1bcf5fde4">[email protected]</span></a> 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:
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OMB control
21 CFR Part Topic No.
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807, subpart E.................... Premarket 0910-0120
Notification.
800, 801, and 809................. Medical Device 0910-0485
Labeling
Regulations.
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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
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