April 25, 2020

Link to the Policy Document: https://www.fda.gov/media/136939/download

The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public Health Emergency. Release of the policy is intended to help expand the availability of digital health therapeutic dev...

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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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