On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring devices used for patient monitoring at the conclusion of the COVID-19 public health emergency (PHE). Specifically, the FDA will continue to allow most remote monitoring devices to be used in home settings and to allow certain hardware or software changes to allow for increased remote monitoring capabilities under enforcement discretion.

At the onset of the COVID-19 pandemic, FDA issued in March 2020 a previous version of the guidance (March 2020 guidance) to help expand the availability and capability of non-invasive remote monitoring devices. FDA announced in March 2023 that it would issue additional policies to continue flexibilities for non-invasive remote monitoring devices in the post-PHE environment. The FDA’s Final Guidance includes the following major changes in policy:

  • Scope: The Final Guidance applies to most of the same types of subject devices that were included in the previous version of the guidance. Notably, however, the FDA removed from the scope the oximeter and clinical electronic thermometer device types. Subject devices included in the Final Guidance are listed in the table below.
  • Policy: Manufacturers of the non-invasive remote monitoring devices listed in the below table are required to submit a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act to FDA, receive FDA clearance prior to marketing these devices (to the extent the devices are not 510(k) exempt), and comply with post-marketing requirements.

The Final Guidance states that for the non-invasive remote monitoring devices covered by the policy, FDA will permit “limited modifications to the indications, functionality, or hardware or software” without prior submission of a premarket notification (510(k)) where such submission would be required, “when the modification does not create undue risk and does not directly affect the physiological parameter measurement algorithm.” Examples of modifications to subject devices that FDA intends to permit with an additional 510(k) filing include:

  • For subject devices previously marketed only for use in hospitals or other health care facilities, a change to the indications regarding use in the home setting; and
    • Hardware or software changes to allow for increased remote monitoring capability.

The FDA states that this policy is intended to advance health equity by increasing access to digital health technologies and 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.

  • Labeling Recommendations: FDA recommends that the subject devices use labeling that helps users better understand the device. FDA recommends that the labeling include a clear description of the available data on the device’s new indications or functions (i.e., device performance and potential risk) and information on use conditions, in particular, whether the device is intended for spot-checking, trend monitoring, or continuous monitoring. In addition, 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, the FDA recommends that manufacturers include adequate instructions, in lay terminology, for at-home use.

The FDA states that it will not receive public comments and that the Final Guidance was implemented immediately upon its publication. However, 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 more information on how this guidance impacts your organization, please contact the professionals listed below, or your regular Crowell Health Solutions contact.

Table 1: Scope of Subject Devices under FDA Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

Device TypeClassification RegulationProduct CodeClass
Gaseous-phase carbon dioxide gas analyzer21 CFR 868.1400CCKII
Diagnostic spirometer21 CFR 868.1840BZG, PNVII
Monitoring spirometer21 CFR 868.1850BZKII
Peak-flow meter for spirometry21 CFR 868.1860BZHII
Breathing frequency monitor21 CFR 868.2375BZQII
Apnea monitor21 CFR 868.2377FLS, NPFII
Noninvasive blood pressure measurement system21 CFR 870.1130DXNII
Electronic stethoscope21 CFR 870.1875DQDII
Cardiac monitor (including cardiotachometer and rate alarm)21 CFR 870.2300DRT, MWI, MSX, PLBII
Electrocardiograph21 CFR 870.2340DPSII
Electrocardiograph software for over-the counter use21 CFR 870.2345QDAII
Radiofrequency physiological signal transmitter and receiver21 CFR 870.2910DRGII
Telephone electrocardiograph transmitter and receiver21 CFR 870.2920DXHII
Audiometer21 CFR 874.1050EWO, LYNII (510(k) exempt)
Otoscope21 CFR 874.4770ERAI (510(k) exempt)
Electroencephalograph21 CFR 882.1400GWQ, OMA, OMB, OMC, OLT, OLU, OLV, OLX, OLZ, ORTII
Computerized cognitive assessment aid21 CFR 882.1470PKQ, PTYII II (510(k) exempt)
Non-electroencephalogram (EEG) physiological signal based seizure monitoring system21 CFR 882.1580POSII
Biofeedback device, sleep assessment device21 CFR 882.5050LELII
Vestibular analysis apparatusUnclassifiedLXVUnclassified