Latest Case for Quality Forum recordings

The latest MDIC June 20 Case for Quality Forum –  Slides and recordings from the event are now available: https://mdic.org/event/​june-20-2019-case-for-quality-forum/.  Specifically the video recording of the update on this program is at:  ​https://www.youtube.com/watch?v=EO2WYAzB4Oc​.  Francisco Vicenty from CDRH also does an update specifically from the CDRH perspective at:  ​https://www.youtube.com/watch?v=EuTtQsNaNCQ​ Advertisements

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