FDA Offers Psychiatric Device Flexibility, Expands ‘Wellness’ Definition

By Kelly Lienhard / April 29, 2020 at 12:53 PM
FDA recently released a temporary enforcement policy stating it does not intend to pursue regulatory action over distribution of unapproved computerized behavioral therapy and other digital health devices during the COVID-19 pandemic. While the agency doesn’t say how it will treat such devices at the end of the pandemic, the guidance appears to expand the agency’s definition of wellness products. Emergency discretion is extended to devices that intend to give patients access to therapy tools used during treatment sessions and...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.