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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. He helped develop and implement CDRH policies in the MedTech space on clinical trials and audits. As Regulatory Counsel, Phil advised FDA leaders on the legal implications of potential compliance actions, pending litigation, enforcing post-market regulatory requirements, and responses to congressional inquiries.

Phil rejoined the firm’s Life Sciences & Healthcare Regulatory practice after serving as counsel earlier in his career.

Credentials

Education

  • J.D., The Catholic University of America, Columbus School of Law, cum laude
  • B.S., Loyola College

Admissions

  • District of Columbia
  • Maryland

Government & Military Service

  • CDRH Regulatory Counsel, Food and Drug Administration, 2005-2009
  • Center for Tobacco Products, Acting Regulatory Counsel, Food and Drug Administration, 2009-2010
  • CDRH Policy Advisor, Food and Drug Administration, 2011-2014
  • CDRH Associate Director for Policy, Food and Drug Administration, 2011-2014
  • Washington, D.C. Industry Representative, Medical Devices Dispute Resolution Panel, Food and Drug Administration, 2017 – Present

Activities

  • Co-chair, Technology and Regulation Committee, Advanced Medical Technology Association, 2017 – 2022
Overview