Greenlight Guru Global Medical Device Podcast with Two Harbors’ George Zack regarding MDDAP

George says, “I have long enjoyed the Global Medical Device podcast series by Greenlight Guru and its host Jon Speer.  I was honored to be a guest on it this past week to discuss the Medical Device Discovery Appraisal Program (#MDDAP) and how MDIC, CDRH at the FDA, the CMMI Institute and participating medical device manufacturers … More Greenlight Guru Global Medical Device Podcast with Two Harbors’ George Zack regarding MDDAP

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

MDICx fourth quarter webinar on #MDDAP is posted

https://www.youtube.com/watch?v=9u7WSidbSRU  The Q4 webinar on the Case for Quality Medical Device Discovery Appraisal Program #MDDAP is posted.  In addition to giving an program status update, this one covers how Edwards Life Sciences leveraged their CMMI discovery appraisal as part of their improvement efforts and what regulatory benefits they have received.  Contact any of us at Two Harbors … More MDICx fourth quarter webinar on #MDDAP is posted