2min chapter

Let’s Talk Medtech cover image

Exploring FDA's Stance on LDTs & AI

Let’s Talk Medtech

CHAPTER

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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