FDA’s New Enforcement Policy: A Win for Remote Patient Monitoring and Remote Therapeutic Monitoring Manufacturers

On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued Guidance for Industry and FDA Staff titled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring (guidance). This guidance updates previous guidance issued during the COVID-19 pandemic and is meant to provide clarity on current enforcement policies now that the public health emergency is declared over….
By: Foley & Lardner LLP