AI in clinical medicine and healthcare

“By law and institutional culture, FDA seeks to apply a single tool to its approach to regulation – the requirement for pre-market approval. The agency is accustomed to compelling innovators to submit evidence to FDA and seek permission for marketing.”

Scott Gottlieb, former FDA director

We discussed the past – and some aspects of the current – regulatory framework of medical devices last week, and we will add to the discussion this week on the FDA approval process and its evolution.

The term “FDA approval” means that the FDA has determined that the benefits of the device…