Innovations in medical device technology hold the potential to improve health outcomes across the populace. But these same innovations can inflict widespread harm; by some estimates, medical devices caused 1.7 million injuries and 83,000 deaths between 2008 and 2017. Hence, we need for a regulatory system that ensures safety while simultaneously permitting—or ideally, fostering—innovation. Over the past half-century, Congress and the FDA have created a unique and complex regulatory system that seeks to achieve these goals. But according to many critics, this system is far too lax, allowing devices to reach the market without an adequate assessment of safety; others maintain that FDA regulation is stifling innovation and depriving patients of valuable technology.
This talk will focus on some of the perennial shortcomings of medical device regulation, on how the regulatory framework might be altered to achieve its goals, and, in an era of changing administrative priorities and limited agency resources, on how we might begin to move forward.
Title:
Medical Device Regulation: Going from Bad to Worse . . . or Better? with George Horvath
The Elena and Miles Zaremski Law Medicine Forum
Webinar Date+Time:
Wednesday, October 29th, 2025
12:00 PM - 1:00 PM Eastern Time
Register Now For This Free Continuing Legal Education Webinar!
(In-Person for Students; Virtual for Non-Students)
Speaker:
 |
| George Horvath |
By:
Case Western Reserve University School of Law
Credit:
- Ohio: 1 hour of online CLE credit, pending approval
- Other Jurisdictions: You may be able to self-apply to your credit-granting authority.
Free and open to the public.
