Washington, DC
Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.
Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.
- Obtained multiple favorable Medicare National Coverage Determinations (NCDs), including under FDA/CMS parallel review.
- Earned approval of a Coverage with Evidence Development (CED) protocol from CMS.
- Obtained multiple favorable Medicare local coverage determinations (LCDs).
- Thomson Reuters, Stand-out Lawyer – independently rated lawyers, 2024-2026
- American Health Lawyers Association
- Food and Drug Law Institute
- Wake Forest University School of Law, JD, magna cum laude
- University of Maryland, BS, summa cum laude
- District of Columbia
- Maryland
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