MCRA’s Alex Cadotte, who just finished a six-year stint with the Imaging Software Team in FDA’s Division of Radiological Health, and Gregory Ramina, who directs regulatory affairs at Viz.ai, one of the first firms to bring a pure AI tool through the agency, talk to Market Pathways about FDA’s evolving approach to AI devices and the direction in which they hope things proceed.
Artificial intelligence in the medical device space is evolving quickly and FDA is trying to make the best of its existing regulatory framework to keep up. Exactly how the agency will handle constantly evolving AI technologies in a way that ensures a reasonable assurance of safety and effectiveness, but doesn’t lead to unsustainable compliance costs for a field of mostly smaller start-ups, still remains to be seen. The current state of play was established largely by FDA’s experience with the first cohort of AI-forward device firms that started submitting premarket submissions within the past five years. Market Pathways sat down with two experts who have been in the AI regulatory trenches.