AP
Arnold & Porter
Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
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.
United States
Food, Drugs, Healthcare, Life Sciences
To print this article, all you need is to be registered or login on Mondaq.com.
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.
Webinar Series Alert
Part VII: FDA and FTC’s Role in MedTech Promotion and
Advertising
Thursday, August 21
11 a.m.-noon ET
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
link