Bakul Patel Leaving CDRH After 13 Years

After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel has announced he will be leaving the agency early this month to explore an undisclosed new chapter in his professional life.

In an announcement on his Linkedin page, Patel said: “It truly has been an incredible journey since 2008, — from introducing the concept of ‘functionality-based regulations’ in the agency’s mobile medical apps guidance; a foundational policy that marked the beginning of a new approach by CDRH to these emerging technologies that was eventually incorporated into law —  to working with international regulators to create the term #SaMD [software as a medical device] — to developing #fdaprecert [device precertification] — to proposing an approach and an action plan for #AI/ML [artificial intelligence/machine learning] medical devices — to building an exceptional #team – and to ultimately launching the Digital Health Center of Excellence #DHCoE.”