FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic

Regulatory NewsRegulatory News | 20 March 2020 |  By 

The US Food and Drug Administration (FDA) released guidance on Friday saying it does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices that are used to support patient monitoring during the pandemic.

Examples of possible modifications include the inclusion of monitoring statements related to patients with COVID-19 or co-existing conditions (e.g., hypertension or heart failure); changes to the indications or claims for devices used in hospitals or other health care facilities so they can be used in the home setting; and hardware or software changes to allow for increased remote monitoring capability.

But examples of circumstances where FDA currently believes a modification would create an undue risk include if the device is intended to be solely or primarily relied upon by the health care professional or patient to make a clinical diagnosis or treatment decision pertaining to COVID-19 or coexisting conditions.

Also potentially creating an undue risk, FDA says, are modifications that add the functionality to acquire, process or analyze a pattern or signal from a signal acquisition system that was not present in the FDA-cleared device.

The guidance also offers examples of non-device functions for clinical decision support software under section 520(o) of the FD&C Act, which the 21st Century Cures Act added so certain software functions could be excluded from the definition of device.

The guidance includes a few examples but notes that for each, the healthcare provider should not rely primarily on the software’s recommendation, including: “A software function that is intended to analyze medical information about a patient diagnosed with COVID-19, such as temperature and heart rate, to provide recommendations to the health care professional for opportunities for additional monitoring or care.” Also included is software “that provides healthcare providers with recommendations on the use of a medical device to treat a patient with confirmed or suspected COVID-19 that are consistent with the FDA-required labeling or that are described in other sources.”

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency


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