Understanding current and upcoming Congressional and FDA initiatives and changes is critical for both strategic planning and for achieving specific objectives such as obtaining a premarket approval or clearance. Yet the nature and pace of these changes is constantly changing and hard to track or predict. Major personnel movement into and out of the agency further complicate the situation. This session will provide the latest information regarding what Congress is considering and what is happening at FDA and CDRH. Specific Congressional and agency actions will be identified and analyzed. With this information, stakeholders will have a better understanding of what is happening in D.C. and will be better positioned to plan, respond proactively, and advance their goals.
Session Chair:
- Ralph Hall, Hall Strategies, LLC
Panelist:
- Philip Desjardins, Arnold & Porter
- Mike Ryan, ELIQUENT Life Sciences
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Presentation Details
Philip Desjardins, JD
Partner
Arnold & Porter
Bio: Philip Desjardins brings 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, diagnostics, 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.
Ralph Hall, JD (Session Chair)
CEO
Hall Strategies, LLC
Professor of Practice (retired)
University of Minnesota Law School
Bio: Mr. Hall leads Hall Strategies assisting clients with FDA matters. Prior positions include serving as a Principal at Leavitt Partners, teaching at the University of Minnesota Law School and senior positions with Eli Lilly and Guidant Corporation including serving as General Counsel of CPI/Guidant CRM. He has also been in private practice.
He has testified before Congressional committees and authored approximately 40 articles. Mr. Hall served as CEO of a start-up medtech entity and is a co-inventor on 6 patents.
He graduated from the University of Michigan Law School.
Mike Ryan, BSBME
EVP
ELIQUENT Life Sciences
Bio: Mike Ryan recently joined ELIQUENT as an Executive VP after 21 years at FDA in CDRH. As a reviewer, TPLC division director, and policy leader, he reviewed hundreds of submissions, shaped key guidance, and drove regulatory modernization. Known for strategic problem-solving, Mike champions innovation in areas of unmet patient needs.