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# Bakul Patel Leaving CDRH After 13 Years
- URL: https://www.fdaweb.com/bakul-patel-leaving-cdrh-after-13-years/
- Published: 2022-05-02T12:00:00.000Z
- Updated: 2026-09-14T17:42:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151724

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](https://www.linkedin.com/posts/bakul-patel%5Ffda-samd-fdaprecert-activity-6926215215214735360-jMeH?utm%5Fsource=linkedin%5Fshare&utm%5Fmedium=ios%5Fapp) 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](https://www.linkedin.com/signup/cold-join?session%5Fredirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Ffeed%2Fhashtag%2Fsamd&trk=public%5Fpost%5Fshare-update%5Fupdate-text&ref=fdaweb.com) \[software as a medical device\] — to developing [#fdaprecert](https://www.linkedin.com/signup/cold-join?session%5Fredirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Ffeed%2Fhashtag%2Ffdaprecert&trk=public%5Fpost%5Fshare-update%5Fupdate-text&ref=fdaweb.com) \[device precertification\] — to proposing an approach and an action plan for [#AI](https://www.linkedin.com/signup/cold-join?session%5Fredirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Ffeed%2Fhashtag%2Fai&trk=public%5Fpost%5Fshare-update%5Fupdate-text&ref=fdaweb.com)/ML \[artificial intelligence/machine learning\] medical devices — to building an exceptional [#team](https://www.linkedin.com/signup/cold-join?session%5Fredirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Ffeed%2Fhashtag%2Fteam&trk=public%5Fpost%5Fshare-update%5Fupdate-text&ref=fdaweb.com) – and to ultimately launching the Digital Health Center of Excellence [#DHCoE](https://www.linkedin.com/signup/cold-join?session%5Fredirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Ffeed%2Fhashtag%2Fdhcoe&trk=public%5Fpost%5Fshare-update%5Fupdate-text&ref=fdaweb.com).”