FDA announces next steps in Digital Health Precertification Program

On January 7, CDRH released its latest update regarding their direction for the Digital Health Precertification program.  https://www.raps.org/news-and-articles/news-articles/2019/1/fda-to-test-precert-de-novo-requests-under-pilot

The update is significant in that it provides several shifts not previously documented – including leveraging the De Novo approach for SaMD products in the pilot.  Additional comments regarding interpretation on this announcement is at:  https://www.linkedin.com/feed/update/urn:li:activity:6488161308070985728

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