Devices

FDA Wants Feedback on Device GenAI Discussion Paper

FDA is soliciting stakeholder feedback on a discussion paper outlining considerations for regulating AI-enabled medical devices. The paper says generative artificial intelligence (GenAI)-enabled medical devices “hold transformative promise for patient care and the broader health ecosystem.” It also says such devices may introduce unique risks when compared to traditional software and artificial intelligence-enabled medical devices.

The agency asks for feedback on these discussion questions:

whether a two-axis risk framework organized around device activity and the consequence of relying on an incorrect output appropriately captures the dimensions most relevant to the risk of a GenAI-enabled software function;
how to account for the spectrum of GenAI-enabled informational functions that vary in the degree to which they direct a user to a particular action;
whether and when a GenAI-enabled function that results in delivery of clinical information to patients, as opposed to healthcare providers, could present different or higher risks, while also recognizing the potential benefits associated with improved patient empowerment, engagement, and access to clinical information;
whether and how the distinction between generalist and specialist physicians might inform the assessment of risk for healthcare provider-facing GenAI-enabled functions;
how risk should be assessed across realistic conversational trajectories for multi-turn conversational GenAI-enabled devices that may migrate from providing non-directive information to action-directing information over the course of an exchange; and
how an evaluation may account for both under-escalation and over-escalation for GenAI-enabled care escalation functions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome