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

U.S. Food and Drug Administration sent this bulletin at 04/28/2022 09:35 AM EDT

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CDRH Medical Device Safety Communication

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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.

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Questions?

If you have questions about digital health policies, email digitalhealth@fda.hhs.gov.