The Food and Drug Administration has released a discussion paper on how it might regulate generative artificial intelligence in medical devices and opened a public comment period that runs through October 19, a step that puts the safety questions surrounding clinical AI in front of patients rather than only industry.
The paper came from the agency's Center for Devices and Radiological Health and its Digital Health Center of Excellence on Tuesday. It poses 26 questions covering risk assessment, premarket evaluation, and postmarket monitoring, and it is explicitly not guidance. The FDA stated that the document does not propose or implement policy changes and is intended to gather early input. The paper itself states that it is for discussion purposes only and does not address whether the described approaches fall within the agency's existing legal authority.
