Key Takeaway: The FDA’s recent discussion paper seeking feedback regarding the regulation of generative AI-enabled medical devices suggests that the FDA has focused on evaluating, monitoring, and regulating such devices amid increasing commercialization.
The United States Food and Drug Administration (“FDA”) recently issued a discussion paper that sought feedback regarding the regulation of generative artificial intelligence-enabled medical devices. Statements from the FDA highlight both the transformative promise and the unique risks provided by generative artificial intelligence-enabled medical devices.
Kyle Diamantas, the acting FDA commissioner, stated:
“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly … [t]oday’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”
The discussion paper proposes a two-axis framework for evaluating the risk of generative artificial intelligence where one axis is the activity performed by the function and another axis is the consequence of relying on an incorrect input. The discussion paper questions whether these are the correct dimensions for evaluating the risk of generative artificial intelligence and requests feedback regarding other potential dimensions. The discussion paper also proposes a competency-based approach for premarket evaluation of generative artificial intelligence-enabled medical devices based on how human clinicians are evaluated.
In a statement, Rick Abramson, the director of the Digital Health Center of Excellence, indicated that “[g]enerative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era … [t]his discussion paper advances the frontiers of regulatory science and propels a critical conversation about how to enable beneficial innovation, protect public health, and preserve trust.”
The FDA’s issuance of the discussion paper suggests that the agency views generative artificial intelligence-enabled medical devices as an emerging medical technology and reflects the FDA’s focus on evaluating, monitoring, and regulating such devices amid increasing commercialization.
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