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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.
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