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Exploring FDA's Stance on LDTs & AI

Let’s Talk Medtech

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Role of Mintz in FDA regulatory pathways and strategies for medical device companies

The chapter discusses Mintz's role in helping medical device companies navigate FDA regulatory pathways and strategies, with a focus on pre-market regulatory pathways, obtaining marketing authorization, and maintaining compliance. They also mention their expertise in AI and machine learning-enabled software and providing advice on avoiding FDA regulation.

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