Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath

Wednesday, October 29th, 2025
12:00 PM - 1:00 PM

Add to Calendar: Add to Calendar: 2025-10-29 12:00:00 2025-10-29 13:00:00 Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Event Description The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath 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. Speaker Bio George Horvath joined the UC Law SF faculty as an Associate Professor of Law in 2024. His scholarship combines his background as a practicing physician and medical scholar with empirical and doctrinal legal analysis to study the fraught intersections of law and health care.  His work examines the ways in which statutory, regulatory, and implementation choices about the FDA’s role in regulating medical devices and drugs has impacted safety and innovation. Prior to joining the UC Law SF faculty, Professor Horvath was an Assistant Professor of Law at the University of Akron School of Law. He was a postdoctoral Fellow in Public Law at the University of California, Berkeley, School of Law. He clerked for Judge John T. Noonan, Jr. on the Ninth Circuit Court of Appeals. Professor Horvath earned his J.D. at Berkeley Law, where he served as Editor-in-Chief of the California Law Review. Prior to his legal career, Professor Horvath earned his M.D. at Temple University Medical School and practiced as a cardiologist specializing in the study and treatment of heart rhythm disorders. In-Person for Students; Virtual for Non-Students School of Law School of Law America/New_York public

1.0 hour of CLE credit has been approved

Event Description

The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath

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.

Speaker Bio

George Horvath joined the UC Law SF faculty as an Associate Professor of Law in 2024. His scholarship combines his background as a practicing physician and medical scholar with empirical and doctrinal legal analysis to study the fraught intersections of law and health care.  His work examines the ways in which statutory, regulatory, and implementation choices about the FDA’s role in regulating medical devices and drugs has impacted safety and innovation.

Prior to joining the UC Law SF faculty, Professor Horvath was an Assistant Professor of Law at the University of Akron School of Law. He was a postdoctoral Fellow in Public Law at the University of California, Berkeley, School of Law. He clerked for Judge John T. Noonan, Jr. on the Ninth Circuit Court of Appeals. Professor Horvath earned his J.D. at Berkeley Law, where he served as Editor-in-Chief of the California Law Review. Prior to his legal career, Professor Horvath earned his M.D. at Temple University Medical School and practiced as a cardiologist specializing in the study and treatment of heart rhythm disorders.

Event Location

In-Person for Students; Virtual for Non-Students

George Horvath