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
