There has been a rise in development of Clinical decision support (CDS) and wellness technologies by medical device manufacturers. Recent FDA policy developments have refined the boundaries between non-device CDS, regulated software functions, and wellness claims, creating both new opportunities and new compliance challenges for developers and regulatory professionals. In this webinar policy and regulatory experts will examine these evolving policies and their practical implications for CDS and Wellness devices manufacturers and regulatory professionals.
Registration Fees & Deadlines
Member: $0 | Nonmember: $25 | Student Members: $0
Who Should Attend?
- Digital Health & Software Product Leaders
- Regulatory Affairs Professionals
- Legal, Policy, and Compliance Professionals
- Startup Founders and Executive Leadership
- Clinical Innovation and Health System Stakeholders
- Quality, Risk, and Patient Safety Leaders
- Investors, Accelerators, and Venture Advisors
Discussion Topics
- What’s New in FDA Guidance on CDS and Wellness
- Legal and Compliance Implications of the Updates
- Impact on Product Design, Claims, and Development
- Case Scenarios: Where the Line Gets Blurry
- Audience Q&A
Speakers
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.
Mike Ryan
Executive Vice President, Eliquent
Mike Ryan brings a rare combination of regulatory depth and strategic vision to his role as Executive Vice President. With over 21 years of experience at the U.S. Food and Drug Administration, Mike has worked across the full regulatory spectrum – premarket review, compliance, postmarket surveillance, and policy development – giving him a truly comprehensive view of the medical device landscape.
During his tenure at FDA, Mike served as a lead premarket reviewer and a Total Product Life Cycle (TPLC) manager across multiple product areas. He played a central role in modernizing regulatory processes as a regulatory advisor and senior leader in CDRH. His contributions include reviewing and overseeing hundreds of premarket submissions, developing dozens of regulations and guidance documents, and leading continuous improvement and transformative initiatives in compliance and postmarket surveillance.
Moderator:
Bahram Parvinian, PhD
Principal Consultant, Lighthouse Regulatory Consulting
Bahram Parvinian, PhD Principal Consultant, Lighthouse Regulatory Consulting. Bahram Parvinian is a senior regulatory affairs leader with 18+ years of experience across FDA, regulatory affairs, and industry consulting, including 12 years at the U.S. FDA leading regulatory strategy for complex software driven and physiological monitoring devices.
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