Exploring FDA's Stance on LDTs & AI

Benjamin Zegarelli, counsel with Mintz, gives some important regulatory updates surrounding laboratory-developed tests, artificial intelligence, and software.

Omar Ford

December 12, 2023

35 Min Listen

What is FDA's stance on laboratory-developed tests? How will FDA handle SaMD developers and software as a service (SaaS) companies, especially those designing software that incorporates artificial intelligence (AI) or machine learning (ML) functionalities?

Benjamin Zegarelli, an attorney with Mintz, discusses FDA's view on these subjects for this episode of the Let's Talk Medtech Podcast.

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like