Contains Nonbinding Recommendations
Enforcement Policy for Non-Invasive 
Remote Monitoring Devices Used to 
Support Patient Monitoring
Guidance for Industry and
Food and Drug Administration Staff
Document issued on October 19, 2023.
This document 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.
For questions about this document, contact the Office of Product Evaluation and Quality (OPEQ) 
Regulation, Policy, and Guidance staff at RPG@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2023-D-4356. Comments may not be 
acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 
GUI00020014 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ......................................................................................................................... 1
II.  Scope ................................................................................................................................... 3
III.  Policy .................................................................................................................................. 5
A.  Modifications to Indications or Functionality..................................................................... 6
B.  Modifications to Hardware or Software Intended to Increase Remote Monitoring 
Availability or Capability ................................................................................................... 7 Contains Nonbinding Recommendations
Enforcement Policy for Non-Invasive 
Remote Monitoring Devices Used to 
Support Patient Monitoring
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  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.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction 
The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the 
United States from threats such as emerging infectious diseases, including the Coronavirus 
Disease 2019 (COVID-19) pandemic and public health emergencies (PHEs). 
Following the emergence of COVID-19, FDA first issued this guidance in March 2020 to 
provide a policy to help expand the availability and capability of non-invasive remote monitoring 
devices to address the PHE. At the time, FDA stated that the policy described in this guidance 
was intended to remain in effect only for the duration of the public health emergency related to 
COVID-19 declared by the Secretary of Health and Human Services (HHS) in accordance with 
section 319 of the Public Health Service Act (PHS Act). On March 13, 2023, FDA announced in 
the Federal Register notice Guidance Documents Related to Coronavirus Disease 2019 
(COVID-19),1 that this guidance document was being revised to continue in effect for 180 days 
after the COVID-19 PHE declaration expires, and that, during that time, FDA intends to further 
revise the guidance.
Non-invasive remote monitoring devices are used to acquire patient physiological data without 
the need for in-clinic visits and facilitate patient management by healthcare providers while 
reducing the need for in-office or in-hospital services. The policy set forth in this guidance was 
initially intended to facilitate patient monitoring while reducing patient and healthcare provider 
1Guidance Documents Related to Coronavirus Disease 2019 (COVID-19) (88 FR 15417), available at 
https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-
disease-2019-covid-19.
1 Contains Nonbinding Recommendations
contact and exposure to COVID-19 by helping to expand the availability and capability of non-
invasive remote monitoring devices during the COVID-19 PHE. Since first issuing 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 in March 2020, FDAs experience has demonstrated that the public health equities 
weigh in favor of exercising certain enforcement policies for these 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. More specifically, FDA has evaluated the benefits 
and risks to patients and healthcare providers of exercising certain enforcement policies, 
including identifying certain device types for which enforcement policies might be appropriate, 
and assessing other lessons learned from implementation of COVID-19-related enforcement 
policies for certain device types. Although this guidance has been revised to remove any 
expiration date for the enforcement policy, among other things, FDA intends to continue to 
monitor the situation and may make further revisions to the guidance, withdraw the guidance, or 
pursue other regulatory actions, as appropriate.
For the current edition of the FDA-recognized consensus standards referenced in this document, 
see the FDA Recognized Consensus Standards Database.2 If submitting a Declaration of 
Conformity to a recognized standard, we recommend you include the appropriate supporting 
documentation. For more information regarding use of consensus standards in regulatory 
submissions, refer to the FDA guidance titled Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical Devices.3
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 Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 
10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome 
policy that is consistent with public health. This guidance document is being implemented 
immediately, but it remains subject to comment in accordance with the Agencys good guidance 
practices.
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.
2Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
3Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices.
2 Contains Nonbinding Recommendations
II. Scope 
The enforcement policy described in this guidance applies to modified devices where the original 
device was a legally marketed, non-invasive remote monitoring device4 listed in Table 1 that 
measures or detects common physiological parameters and that is used to support patient 
monitoring:
Table 1
Device Type Classification  Product Code5 Class6
Regulation
Gaseous-phase carbon- 21 CFR 868.1400 CCK II
dioxide gas analyzer
Diagnostic spirometer 21 CFR 868.1840 BZG, PNV II
Monitoring spirometer  21 CFR 868.1850 BZK II
Peak-flow meter for  21 CFR 868.1860 BZH II
spirometry
Breathing frequency  21 CFR 868.2375 BZQ II
monitor
Apnea monitor 21 CFR 868.23777 FLS, NPF II
Noninvasive blood  21 CFR 870.1130 DXN II
pressure measurement 
system
Electronic stethoscope 21 CFR 870.18758 DQD II
Cardiac monitor  21 CFR 870.2300 DRT, MWI, MSX,  II
(including  PLB
cardiotachometer and 
rate alarm)
Electrocardiograph  21 CFR 870.2340 DPS II
Electrocardiograph  21 CFR 870.23459 QDA II
software for over-the-
counter use
4Examples may include wearable, hand-held, stationary in-home monitoring, and digital interfaces.
5For more information, see the Product Classification Database, available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
6Some devices with the product codes listed in Table 1 are exempt from premarket notification requirements in 
section 510(k) of the FD&C Act (see 21 CFR 807.81), subject to the limitations in 21 CFR 874.9 and 882.9. 
However, FDA believes that some modifications to these devices to facilitate remote patient monitoring would 
trigger the requirement that a manufacturer submit a premarket notification because such modifications would 
exceed the limitations of the exemption as identified in 21 CFR 874.9 and 882.9.  
7Devices in this classification regulation are subject to special controls, including general performance 
testing/validation requirements. See 21 CFR 868.2377.
8This classification regulation pertains to both manual and electronic stethoscopes. Manual stethoscopes are class I 
devices and are outside the scope of this guidance.
9Devices in this classification regulation are subject to special controls, including general performance 
testing/validation requirements. See 21 CFR 870.2345.
3 Contains Nonbinding Recommendations
Radiofrequency  21 CFR 870.2910 DRG II
physiological signal 
transmitter and 
receiver
Telephone  21 CFR 870.2920 DXH II
electrocardiograph 
transmitter and 
receiver
Audiometer 21 CFR 874.1050 EWO, LYN II (510(k) exempt)10
Otoscope 21 CFR 874.4770 ERA I (510(k) exempt)11
Electroencephalograph 21 CFR 882.1400 GWQ, OMA, OMB,  II
OMC, OLT, OLU, 
OLV, OLX, OLZ, 
ORT
Computerized  21 CFR 882.147012 PKQ II
cognitive assessment  PTY II (510(k) exempt)13
aid
Non- 21 CFR 882.158014 POS II
electroencephalogram 
(EEG) physiological 
signal based seizure 
monitoring system
Biofeedback device,  21 CFR 882.5050 LEL II
sleep assessment 
device
Vestibular analysis  Unclassified  LXV Unclassified15
apparatus
10While audiometers, if in compliance with American National Standard Institute S3.6-1996, "Specification for 
Audiometers, are generally exempt from premarket notification requirements in section 510(k) of the FD&C Act 
(see 21 CFR 807.81), subject to the limitations in 21 CFR 874.9, otoacoustic emission devices are not so exempt. 21 
CFR 874.1050(b). Both the 510(k)-exempt and non-exempt devices described in 21 CFR 874.1050 are within the 
scope of this guidance.
11Although devices with this product code are class I and generally 510(k) exempt, many otoscopes have been 
cleared through the premarket notification process because they have exceeded the limitations of exemption 
identified in 874.9. FDA believes that modifications to existing otoscopes to allow for increased remote monitoring 
capability may similarly trigger the requirement that a manufacturer submit a premarket notification; therefore, this 
product code has been included within the scope of this guidance. 
12Devices in this classification regulation are subject to special controls. See 21 CFR 882.1470.
13Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases 
or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, a computerized 
cognitive assessment aid is exempt from premarket notification requirements in section 510(k) of the FD&C Act 
(see 21 CFR 807.81) subject to the limitations in 21 CFR 882.9. See 21 CFR 882.1470(b).  
14Devices in this classification regulation are subject to special controls. See 21 CFR 882.1580. 
15Unclassified devices are preamendments devices for which FDA has not yet promulgated a classification 
regulation. Until the unclassified device type has been classified through regulation, marketing of new devices 
within this device type requires submission of a premarket notification under section 510(k) of the FD&C Act.  
4 Contains Nonbinding Recommendations
These non-invasive monitoring devices have the potential to be connected to a wireless network 
through Bluetooth, Wi-Fi, or cellular connection to transmit a patients measurements directly to 
their healthcare provider or other monitoring entity. 
The Oximeter (21 CFR 870.2700) and Clinical electronic thermometer (21 CFR 880.2910) 
device types have been removed from Table 1 compared to the prior versions of FDAs guidance 
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient 
Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
III. Policy 
Manufacturers of the non-invasive remote monitoring devices listed in Table 1 are required to 
submit a premarket notification under section 510(k) of the FD&C Act to FDA and receive FDA 
clearance prior to marketing these devices in the United States, to the extent the devices are not 
510(k) exempt, as well as comply with post-marketing requirements.
At this time, based on our current understanding of the risks of these devices, FDA does not 
intend to object to limited modifications to the indications, functionality, or hardware or software 
of certain non-invasive remote monitoring devices that are used to support patient monitoring 
(hereinafter referred to as subject devices) without prior submission of a premarket notification 
(510(k)) under section 510(k) of the FD&C Act (see 21 CFR 807.81) where such submission 
would be required16,17 when the modification does not create undue risk and does not directly 
affect the physiological parameter measurement algorithm. Examples of such modifications 
include: 
 For subject devices previously marketed only for use in hospitals or other healthcare 
facilities, a change to the indications regarding use in the home setting; and
 Hardware or software changes to allow for increased remote monitoring capability.
In developing this policy, FDAs intent is to foster the availability of certain non-invasive remote 
monitoring devices that can help eliminate unnecessary patient contact and ease burdens on 
hospitals, other health care facilities, and health care professionals, which are experiencing high 
demands. Additionally, this policy is consistent with CDRHs 2022-2025 strategic priorities18
focusing on advancing health equity, which includes increasing access to digital health 
technologies that can advance better care, quality of life, and wellness of diverse populations. 
16For further guidance on modifications that trigger the requirement that a manufacturer submit a new 510(k) to 
FDA, refer to the FDA guidances Deciding When to Submit a 510(k) for a Change to an Existing Device, available 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device, and Deciding When to Submit a 510(k) for a Software Change to an Existing Device, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-
change-existing-device.
17Certain modifications to the indications, functionality, or hardware or software of 510(k)-exempt devices in Table 
1 may require premarket notification if they exceed the limitations of the exemption under 21 CFR 874.9 and 21 
CFR 882.9, respectively.
18For details, see the webpage CDRH Strategic Priorities and Updatesavailable at https://www.fda.gov/about-
fda/center-devices-and-radiological-health/cdrh-strategic-priorities-and-updates.
5 Contains Nonbinding Recommendations
This policy supports this strategic priority and is intended to lessen the burden on both 
manufacturers and FDA by reducing the number of 510(k) submissions caused by certain 
modifications to allow for remote monitoring. As always, FDA may make case-by-case decisions 
regarding the enforcement of legal requirements in response to particular circumstances and 
questions that arise regarding a specific device or device type. FDA notes that the enforcement 
policy in this guidance does not address any legal requirements other than premarket notification.
A. Modifications to Indications or Functionality 
At this time, FDA does not intend to object to limited modifications to the indications or 
functionality of the subject devices that allow for increased remote monitoring capability without 
prior submission of a 510(k) where the modification does not create undue risk and does not 
directly affect the physiological parameter measurement algorithm. FDA generally believes such 
a modification to the indications to allow for use in the home setting does not create such undue 
risk and does not affect the physiological parameter measurement algorithm.
In contrast, modifications to the indications or functionality that could create such undue risk or 
that could affect the physiological parameter measurement algorithm would not be within the 
scope of this policy and would generally require submission of a 510(k).19 For example, 
modifications to add new indications or device software functions20 to allow for remote 
programming of the device, remote control of the device, generation of new alarms, 
measurement of new physiological parameters, or a change from prescription to over-the-counter 
use would not be within the scope of this policy.
FDA is also providing recommendations regarding labeling21 relevant to the enforcement policy 
set forth above. FDA recommends that the subject devices use labeling that helps users better 
understand the device. FDA recommends that the labeling include the following elements:
1) A clear description of the available data on the devices new indications or functions, 
including:
a. Device performance; and
b. Potential risks.
1921 CFR 807.81(a)(3).
20For purposes of this guidance, for any given product, the term function is a distinct purpose of the product, 
which could be the intended use or a subset of the intended use of the product. For purposes of this guidance, a 
device software function is a software function that meets the definition of a device under section 201(h) of the 
FD&C Act. For details, see FDAs guidance Multiple Function Device Products: Policy and Considerations, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-device-
products-policy-and-considerations.
21Unless exempt from the requirement of section 502(f)(1) of the FD&C Act (see 21 CFR Part 801, subpart D), a 
device whose labeling does not bear adequate directions for use is misbranded. FD&C Act sec. 502(f)(1). 21 CFR 
801.5 describes a number of reasons why directions for use may be inadequate. Prescription devices are exempt 
from the requirement of section 502(f)(1) if all of the conditions identified in 21 CFR 801.109(a)-(e)which govern 
the devices labeling, among other thingsare met. See 21 CFR 801.109. Devices within the scope of this guidance 
must follow applicable labeling requirements.
6 Contains Nonbinding Recommendations
2) Information on use conditions, in particular, whether the device is intended for spot-
checking, trend monitoring, or continuous monitoring.
3) For devices previously marketed for use only in a hospital or other healthcare facility and 
for which the environment of use has been expanded to include in-home use, adequate 
instructions for use in the home setting with appropriate lay terminology.
B. Modifications to Hardware or Software Intended to 
Increase Remote Monitoring Availability or Capability 
As described above, at this time, FDA does not intend to object to limited hardware or software 
architecture modifications to subject devices that allow for increased remote monitoring 
capability without prior submission of a 510(k) when the modification does not create undue risk 
and where the modifications do not directly affect the physiological parameter measurement 
algorithm. The manufacturer should also consider the recommendations in Section III.A, as such 
hardware or software architecture modifications made to support patient monitoring may also 
affect the devices indications and functionality.
FDA expects that these types of modifications generally include device connectivity 
modifications (e.g., the addition of wireless and/or Bluetooth capability), which may warrant 
accompanying non-device22 and device hardware or software architecture modifications. Such 
modifications generally do not create undue risk when the applicable FDA-recognized standards 
and guidances are followed, and generally do not affect the physiological parameter 
measurement algorithm; therefore, such a change would generally be within the scope of this 
policy. To address any unique considerations or modifications beyond those described above, 
manufacturers may wish to initiate discussions with FDA by contacting RPG@fda.hhs.gov or 
through the Q-Submission Program.23
FDA recommends any such changes be designed, evaluated, and validated in accordance with 
current FDA-recognized standards, including (as applicable):
 ANSI/AAMI ES60601-1 Medical Electrical Equipment  Part 1: General 
Requirements for Basic Safety and Essential Performance
 IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for 
Basic Safety and Essential Performance  Collateral Standard: Electromagnetic 
Disturbances  Requirements and Tests
22Software functions that are solely intended to transfer, store, convert formats, or display medical device data or 
medical imaging data, unless the software function is intended to interpret or analyze clinical laboratory test or other 
device data, results, and findings, are not devices. See FDAs guidanceMedical Device Data Systems, Medical 
Image Storage Devices, and Medical Image Communications Devices, available athttps://www.fda.gov/regulatory-
information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-
medical-image-communications-devices.
23See FDAs guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-
feedback-and-meetings-medical-device-submissions-q-submission-program.
7 Contains Nonbinding Recommendations
 IEC 60601-1-11 Medical Electrical Equipment Part 1-11: General Requirements for 
Basic Safety and Essential Performance  Collateral Standard: Requirements for 
Medical Electrical Equipment and Medical Electrical Systems Used in the Home 
Healthcare Environment
 Any other applicable collateral/particular standards in the 60601-1 family
 AAMI TIR69 Technical Information Report Risk Management of Radio-Frequency 
Wireless Coexistence for Medical Devices and Systems
 ANSI/IEEE C63.27 American National Standard for Evaluation of Wireless 
Coexistence
 IEC 62304 Medical Device Software  Software Life Cycle Processes
 AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity 
Test for Exposure to Radio Frequency Identification Readers
 ANSI/UL 2900-2-1 First Edition 2017  Standard for Safety, Software Cybersecurity 
for Network-Connectable Products, Part 2-1: Particular Requirements for Network 
Connectable Components of Healthcare and Wellness Systems
 IEC 81001-5-1 Health software and health IT systems safety, effectiveness and 
security - Part 5-1: Security - Activities in the product life cycle
The manufacturer must document the change and analysis in accordance with the manufacturers 
quality system.24
In addition, modifications to hardware or software intended to increase remote monitoring 
capability may impact cybersecurity risks. Effective cybersecurity is necessary to ensure the 
safety and functionality of such devices. Manufacturers must follow cybersecurity requirements 
and should follow cybersecurity policies applicable to their devices. The following online 
resources may be helpful in developing and maintaining these cybersecurity controls:
 Content of Premarket Submissions for Management of Cybersecurity in Medical 
Devices;25
24Under the quality system (QS) regulation, [e]ach manufacturer shall establish and maintain procedures for the 
identification, documentation, validation or where appropriate verification, review, and approval of design changes 
before their implementation. 21 CFR 820.30(i). On February 23, 2022, FDA proposed to amend the device current 
good manufacturing practice (CGMP) requirements of the QS regulation, 21 CFR part 820, to align more closely 
with the international consensus standard for devices by converging with the quality management system (QMS) 
requirements used by other regulatory authorities from other jurisdictions (i.e., other countries) (87 FR 10119; 
available at https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-
regulation-amendments). Specifically, FDA proposed to amend the current part 820 by withdrawing the majority of 
the requirements for establishing and maintaining a QS and instead incorporate by reference the 2016 edition of the 
International Organization for Standardization (ISO) 13485, Medical devicesQuality management systems
Requirements for regulatory purposes, in part 820. As stated in that proposed rule, the requirements in ISO 13485 
are, when taken in totality, substantially similar to the requirements of the current part 820, providing a similar level 
of assurance in a firms quality management system and ability to consistently manufacture devices that are safe and 
effective and otherwise in compliance with the FD&C Act. FDA will update references to provisions in 21 CFR part 
820 in guidance documents as appropriate for consistency with revised regulations.
25Available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-
submissions-management-cybersecurity-medical-devices-0.
8 Contains Nonbinding Recommendations
 Postmarket Management of Cybersecurity in Medical Devices;26 and
 FDA Fact Sheet: The FDAs Role in Medical Device Cybersecurity - Dispelling 
Myths and Understanding Facts.27
26Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-
management-cybersecurity-medical-devices.
27Available at https://www.fda.gov/media/123052/download.
9