
[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


