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(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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