Partner
Arnold & Porter
Philip Desjardins brings nearly two decades of experience working with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and serving in pivotal leadership roles in Johnson & Johnson’s MedTech businesses. His comprehensive insights into the intricacies of the FDA's operational framework and regulatory expectations and broad knowledge of the MedTech ecosystem position Phil as a leading authority on MedTech regulatory affairs and compliance. He has consistently delivered successful outcomes to a broad spectrum of clients, from emergent biotech startups to established global healthcare giants.
As CDRH Associate Director for Policy, Phil was key in formulating the FDA’s current policies on medical devices and drug-device combinations, including legislation, regulations, and enforcement actions. Phil has helped negotiate the Medical Device User Fee agreementins for the last three MDUFA cyclces, MDUFA III, IV, & V.
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Opening Plenary: Preparing for the Next Round of User Fee Negotiations
Thursday, June 6, 2024
9:00 AM – 10:15 AM EDT