AFDO RAPS Healthcare Products Collaborative
,dharmesh Patel



Associate Director Regulatory Policy


Dharmesh Patel joined BD in January 2023 as Associate Director, Regulatory Policy. He is developing and advancing BD’s regulatory policy positions with a focus on International Harmonization, Digital Health, Software, and AI/ML. Prior to joining BD, Dharmesh was at FDA/CDRH as the Assistant Director of the PMA, HDE, Q-Submission and Device Lifecycle Tracking policy team. Dharmesh first joined CDRH in 2011 as a lead scientific reviewer in the Division of Cardiovascular Devices and has worked in various policy areas such as Digital Health and the Third Party 510(k) program before moving onto his leadership role in PMA policy. Dharmesh has a Bachelor’s degree in Electrical Engineering, a Master’s degree in Engineering, and a MBA.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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