More Data Sought by FDA on AI-Based Medical Device Submissions

Companies seeking approval for medical devices that contain AI are still asked to jump through the basic regulatory hoops inherent in trying to bring any new device to market -- but now the FDA is increasing its expertise in AI and asking for more data.

That’s according to Kelliann Payne, a partner at the law firm Hogan Lovells and a veteran in the medical device space who spoke at a webinar hosted by AdvaMed on Friday. The FDA is “asking more data questions, putting more emphasis on subgroups, and asking for more details on model development,” said Payne, “They’re digging in in more places.”

Currently, 700 medical devices contain AI software, according to the FDA. Nothing using a large-language model has yet been cleared, though, said Payne, and so far, all algorithms are locked, thus the software can’t yet learn as it continues to gather data from within the patient.

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