Critical Medical Device Series: Part VI Navigating Innovation: The FDA’s Role in Regulating Medical Technology

The U.S. Food and Drug Administration, Center for Devices and Radiological Health (FDA) plays a pivotal role in shaping the future of medical technology innovation, particularly through its pre-market and post-market regulatory oversight. As medtech companies continue to push the boundaries of innovation, understanding how the FDA assesses and monitors safety, effectiveness, and compliance in the context of a pre-market submission and after a product reaches the market is more critical than ever. From post-market surveillance and adverse event reporting to recalls and the use of real-world evidence, the FDA’s evolving regulatory focus can significantly impact product lifecycle management and market strategy.

Arnold & Porter partners Phil Desjardins and Abeba Habtemariam will lead a discussion on the FDA’s current and emerging role in regulating medical technology, focusing on how recent policy updates and organizational changes may influence the agency’s approach moving forward. This session will be particularly valuable for commercial, regulatory, quality, clinical, and legal leaders in the medtech space who are navigating the complexities of compliance, risk, and innovation. Attendees will gain practical insights into how to align their strategies with FDA expectations and anticipate regulatory shifts that could affect their business.

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