FDA Update: Digital Health Policies and Solutions for COVID-19

The update gathers examples of software functions not regulated as medical devices as identified in current FDA guidance documents.

If your email program has trouble displaying this email, view as a webpage. FDA Update: Digital Health Policies and Public Health Solutions for COVID-19 Today, the U.S. Food and Drug Administration (FDA) updated the Digital Health Policies and Public Health Solutions for COVID-19 page to include the FDA's current policies that may support public health innovation in COVID-19-related digital health technologies and the response to COVID-19. This update: Provides examples of software functions identified in guidance documents issued during the COVID-19 public health emergency. Reflects policies and legislation currently in effect, including the software provisions of the 21st Century Cures Act. Identifies many software functions that are not regulated as medical devices, including some that may be useful in the COVID-19 response. Read More Questions? If you have questions about digital health policies, email digitalhealth@fda.hhs.gov.

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