It is “a top priority, and we increasingly see more and more digital health technologies coming to market,” said Shuren. “Just last week we put out a list of over 340 devices that we’ve authorized with artificial intelligence machine learning. To put these efforts on steroids last year, we created a virtual Digital Health Center of Excellence that now brings together our resources across the center and serves as resource for other parts of the agency and the external community to drive new policy changes and test drive new regulatory frameworks.”
In the coming months expect see a plan of action for AI/ML as well as a report on the Precertification pilot. “So far it has been pretty positive and we want to share those findings,” he said.