In our first episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at Regulatory Compliance Associates (RCA), examine the FDA's proposed regulatory framework for modifications to artificial intelligence and machine learning (AI/ML)-based software as a medical device.

We dive into the FDA discussion paper, what AI/ML software are and how they work in medical devices, and discuss how potential risk factors resulting from this software's ability to adapt or change have led the FDA to propose a new total product lifecycle approach, eliciting industry feedback in the process.