State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to medical devices versus drugs

Lexology March 3, 2025
Hogan Lovells

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can vary significantly. Unlike the standardized federal approach, state regulations can differ greatly, making compliance a challenging task for companies operating in multiple jurisdictions.

Because the existence and enforcement of state-based medical device requirements are on the rise and, historically, state-based requirements are crafted with drug manufacturers and distributors in mind, this article compares state-based drug and medical device regulatory regimes to improve understanding of these divergent — but often overlapping — regulatory areas.

This article is the first in our new thought leadership series on the critical and continually evolving state...

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