FDA Issues Emergency Enforcement Policy for Remote Monitoring Devices

By Tricia Kaufman

Last week, FDA published a guidance document, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, effective immediately, outlining a policy to enhance the ability and capability of non-invasive remote monitoring devices to monitor patients while reducing contact between patients and healthcare providers (HCP) to control exposure to COVID-19.

What Devices are Covered under the Guidance Document?

The guidance document applies to FDA-cleared, non-invasive, remote patient monitoring devices that are used to support patient monitoring during the COVID-19 public health emergency, including wearables, hand-held, stationary in-home monitoring and digital interfaces, in the following categories:

  • Clinical Electronic Thermometer
  • Electrocardiograph
  • Cardiac Monitor
  • Electrocardiograph Software for Over-the-Counter Use
  • Pulse Oximetry (SpO2)
  • Non-Invasive Blood Pressure (NIBP)
  • Respiratory Rate/Breathing Frequency
  • Electronic Stethoscope
What Does the Guidance Document Do?

The guidance document explains FDA’s intention not to object to certain limited modifications to the FDA-cleared devices listed above, when made without premarket submission, if they do not create an undue risk in light of the public health emergency, specifically, modifications to:

  • Indications for use (e.g., home use for devices cleared for healthcare settings)
  • Claims (e.g., statements related to COVID-19 or co-existing conditions)
  • Functionality
  • Hardware or software (e.g., changes allowing for increased remote capability)
What is the Purpose of the Policy?

The policy is meant to help eliminate unnecessary patient/provider contact and ease the burden on healthcare facilities and providers resulting from the COVID-19 pandemic, while ensuring access to important patient physiological data.

How Long Will the Policy Be in Effect?

The policy will remain in effect only for the duration of the COVID-19 public health emergency declared by the Department of Health and Human Services on January 31, 2020, including renewals.

What Modifications to Indications for Use, Claims or Functionality Are Acceptable?

According to the guidance, a modification to indications, claims or functionality does not create an undue risk, and therefore may be made without a premarket submission, where:

  • The device is intended to display, print or analyze physiological data measured by the device.
  • The device is intended to support or provide recommendations to the HCP or patient about prevention, diagnosis or treatment of COVID-19 or co-existing conditions.
  • The HCP or patient can independently review the basis for any recommendations.

In contrast, undue risk would arise if the device is: (i) intended to be used for purposes of immediate clinical intervention, (ii) intended to be primarily relied upon to make clinical decisions pertaining to COVID-19 or co-existing conditions; or (iii) modified to add the functionality of acquiring, processing or analyzing a pattern or signal from a signal acquisition system that was not in the FDA-cleared device.

What Labeling Changes Should Accompany These Modifications?

For changes to intended use, claims or functionality, the following elements should be included in the device labeling, even if not required by regulation:

  • A clear description of the data related to COVID-19 or co-existing conditions, including performance data, the method of determining diagnostic or treatment recommendations and potential risks
  • Prominent notice that users should not solely or primarily rely upon the recommendations to prevent, diagnose or treat COVID-19 or co-existing conditions
  • Information on use conditions (particularly if the intended use is for spot-checking, trend monitoring or continuous monitoring)
  • A clear distinction between indications and claims that have been FDA-cleared and those that have not, and a general statement about changes that have not been FDA-cleared
  • For expansions of use from healthcare facility environments to in-home use, adequate instructions for use in lay terminology
What Modifications to Hardware and Software Are Covered by the Policy?

Per the guidance, FDA will permit modifications to hardware or software architecture to increase remote monitoring capability to support additional claims or indications where the modifications do not directly affect the physiological parameter measurement algorithms. An example is adding wireless or Bluetooth capability. Changes should be validated to FDA-recognized standards and should include cybersecurity controls.

The guidance also provides examples of how Clinical Decision Support Software that are not medical devices, and therefore are not FDA regulated, may be used in connection with COVID-19 and co-existing conditions.

What is not clear in the guidance is what will happen when the emergency declaration expires. Specifically, once the declaration is lifted, what will happen to any inventory of product modified pursuant to the emergency policy that otherwise would have required FDA-clearance? Hopefully, FDA will provide further clarity on this issue in the coming weeks.

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