Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “AdvaMed Seeks Regulatory Clarity on FDA’s New Digital Health Center,” by Greg Slabodkin.
Following is an excerpt:
FDA hosted a virtual listening session Monday for groups representing device manufacturers, commercial technology companies, patients and others regarding the agency’s new Digital Health Center of Excellence. …
Patel, who has led the agency’s digital health regulatory and scientific efforts for the past decade, contends that among the center’s fundamental objectives is to provide a consistent application of FDA’s policy and oversight approaches to these emerging technologies. …
AdvaMed’s Rothstein said regulatory clarity will be essential for medical device companies under FDA’s jurisdiction that are developing digital health technologies.
Bradley Merrill Thompson, attorney at Washington, D.C. law firm Epstein Becker Green, said he was disappointed that the FDA did not commit to anything concrete.
“I generally like the fact that FDA seems interested in outside opinion, but of course the proof is not found in a listening session but in action.” …
As for prioritizing clarity on digital health issues in guidance in the coming year, those topics appear to be taking a bit of a backseat to other issues FDA has to work on. Thompson, who serves as general counsel for the AI Startups in Health Coalition, expressed disappointment that CDRH’s recently released annual list of guidance documents assigned a lower Category B priority for the Pre-Determined Change Control Plan: Premarket Submission Considerations for AI and Machine Learning Software document.
“The change control plan has to be the cornerstone of FDA’s new approach to AI, and so for the center to say that that is only a priority B is flatly inconsistent with the messages they seem to be expressing in the listening session,” Thompson added.
