The FDA Breakthrough Device Program:  Purpose, History, and Performance

Speaker: John Doucet, PhD, Vice President, Regulatory Affairs – Neuromodulation and Evolving Technologies. MCRA, LLC, Washington, DC

Short Bio:

John joined MCRA on August 31st, 2020 as Senior Director, Neurology Regulatory Affairs and was promoted to Vice President, Regulatory Affairs on March 18, 2022. At MCRA, John provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies. He has extensive knowledge of medical device regulatory pathways to drive technologies from conception to market. John is a neuroscientist and biomedical engineer with 10+ years of FDA experience in medical device regulation, and 13+ years of Johns Hopkins experience in discovery science, and 6+ years of management experience at FDA and Johns Hopkins School of Medicine.

Prior to joining MCRA, John was the Former US Food and Drug Administration (FDA) Policy Lead, for the Breakthrough Device Program. In this position, John managed the Breakthrough Device Program, where he oversaw all aspects of the program, was involved in the granting or denial of all Breakthrough designation requests, and served as CDRH’s expert for internal and external stakeholders regarding the regulatory standard for obtaining the Breakthrough designation for a medical device.  In addition to John’s leadership role with the FDA Breakthrough Designation Device Program, John also served in additional roles at FDA including Acting Director of IDE Program, Lead Reviewer of Neurology and Physical Medicine Devices, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch, and Policy Analyst of Office of Device Evaluation. 

Prior to joining the FDA, John was an Assistant Professor at Johns Hopkins University where he studied the structure and function of brain pathways that underlie hearing.  He attended Syracuse University where he obtained a BS in Biomedical Engineering and a PhD in Neuroscience.