The American Medical Association (AMA) has responded to the US Food and Drug Administration’s (FDA) call for feedback on its proposed regulatory approach to generative artificial intelligence (GenAI)-based medical devices, asserting that oversight should incorporate a “least-burdensome, risk-based framework” that supports continued innovation in healthcare.
GenAI is widely viewed as the next frontier for AI and is different to existing AI given its ability to undertake autonomous decision-making with limited or no human input.
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Led by the Digital Health Center of Excellence (DHCoE), situated within the FDA’s Center for Devices and Radiological Health (CDRH), the 30-page discussion paper on a potential approach to regulating GenAI-based medical devices was released in August, with the stakeholder feedback period ending on 19 October.
In a letter sent to the FDA’s director Rick Abramson on 16 October, AMA CEO John Whyte emphasised the association’s position that in crafting a regulatory framework for GenAI-based medtech, regulatory agility cannot come at the expense of safety and effectiveness, and that physician expertise should “inform the standards, not serve as the safety net.”
The paper proposed establishing regulatory protocols, including pre-market “competency assessment” to evaluate whether GenAI-enabled medical devices perform as intended, and post-market monitoring dictates to ensure patient safety is maintained over time.
Whyte’s letter agreed with the DHCoE’s assertion that devices with broad intended uses or open-ended inputs and outputs may make it “unreasonable” to evaluate every conceivable input a device could encounter after deployment. He added, however, that these factors should “not be conflated with an inability to establish sufficient evidence of safety and effectiveness” before a market approval.
Meanwhile, Whyte stressed that GenAI-enabled medical devices should require a “more coordinated and stringent” approach to post-market surveillance than relying on monitoring and reporting from individual manufacturers.
Commenting on its input to the DHCoE’s proposal, AMA president Willie Underwood said: “GenAI has the potential to extend the reach of physicians and fundamentally improve how patients receive care. Realising that potential requires new approaches to evaluating technologies that can perform increasingly consequential clinical functions.
“Physicians have a critical role in defining what good performance looks like, and the AMA is ready to help build the evidence and oversight frameworks that will allow trustworthy AI that improves care. Manufacturers must remain accountable for the performance of their products, and patients and physicians deserve the confidence that these technologies are safe and effective.”
