U.S. FDA Issued Guidance on Enforcement of Non-Invasive Remote Monitoring Devices

As the impact of the COVID-19 pandemic continues to challenge the nation’s healthcare system, the U.S. Food and Drug Administration (FDA) has taken steps to ease its enforcement of certain types of remoting patient monitoring devices.

Issued in June, the Guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” is intended to support efforts to expand the availability and capability of suitable monitoring devices that can remotely monitor patients. Remote monitoring is essential in limiting the need for patient-provider contact and can also help provide monitoring support for patients in remote locations.

Specifically, the Guidance states that:

 “… FDA does not intend to object to limited modifications to the indications, claims, 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”), during the declared public health emergency…without prior submission of a premarket notification…”

It is important to note that the easing of FDA’s enforcement policy regarding non-invasive remote monitoring devices as detailed in this Guidance remains in effect only for the duration of the COVID-19 public health emergency. Further, Guidance documents issued by the FDA and other federal agencies are intended solely to provide interested parties with information on the current views of the agency with regard to a specific issue and do not have the force of law.

Read the complete text of the FDA’s Guidance on its enforcement policy for non-invasive remote monitoring devices is available through the FDA’s website.

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