In 2017, CDRH launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing certain regulatory requirements for those who demonstrate quality maturity (https://live-mdic.pantheonsite.io/cfq/enroll/). CDRH expects the pilot to continue through 2018 and MDIC will provide updates on pilot progress, lessons learned, and changes made to the program through this quarterly MDICx webinar series.
This first update webinar featured George Zack from Two Harbors Consulting, Kimberly Kaplan from CMMI, Joe Friedrich from Boston Scientific and Cisco Vicenty from FDA Center for Devices and Radiological Health.
