U.S. FDA Allows Expanded Use of Medical Devices for Remote Patient Monitoring

In an action to support the healthcare system care for patients during the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) will now temporarily allow the expanded use of certain devices to enable healthcare professionals to monitor patients remotely.

According to a new Guidance document issued by the FDA on March 20th, the new policy will expand the permitted use of FDA-cleared, non-invasive, vital sign-measuring devices so that healthcare providers can use them to monitor more patients remotely. Such devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

The FDA says that the new policy remains in effect only for the duration of the current public health emergency declared by the U.S. Department of Health and Human Service (HHS), although the emergency period may be extended at the discretion of the Secretary of HHS.

Read the complete text of the FDA’s new Guidance on the FDA’s enforcement policy for non-invasive remote monitoring devices is available through the Regulations.gov portal.

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