Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA’s Final PCCP Guidance Clarifies Expectations for AI Submissions,” by Cara Smith. (Read the full version – subscription required.)
Following is an excerpt:
FDA on Tuesday (Dec. 3) released highly anticipated final guidance urging sponsors of digital technology to submit predetermined change control plans (PCCP) laying out how they might modify their devices in the future, clarifying the guidance applies broadly to all artificial intelligence-enabled software, including over-the-counter mobile medical apps, and requires product labeling. A key former FDA employee said the updated guidance provides needed clarity but expressed hope the agency will focus its oversight on high-risk devices. …
[Bradley Merrill Thompson] … a regulatory expert at Epstein Becker Green, said the guidance seems to be intended to cover the worst cases or those that pose the greatest risk to the public. “A lot of it seems like overkill for low-risk medical devices,” Thompson said. “Hopefully when it comes time to application, …”
