Michelle Tarver, director of the Center for Devices and Radiological Health, provided an update on digital health and artificial intelligence policy on Friday at the Association for the Advancement of Medical Instrumentation’s neXus conference.
Tarver said the CDRH plans to issue final guidance on AI lifecycle management, and told attendees to watch for the center’s thinking following two advisory committee meetings on generative AI.
The Food and Drug Administration published draft guidance on AI lifecycle management in January 2025. The document outlines best practices to ensure AI-enabled devices are safe and effective, and how developers should address transparency and bias.
All AI algorithms are required to be trained on data that reflects the intended use population and should be validated in the intended use population, Tarver said.
The draft guidance also addresses postmarket monitoring after an AI-enabled device is deployed in the real world, knowing that this technology can hallucinate, bias can come into play and models may drift, or become less accurate over time.
“All of that can impact the output that those technologies are generating and impact patient outcomes as a result,” Tarver said.
The FDA is currently looking at comments from the draft to issue a final guidance, Tarver said.
The CDRH director also addressed generative AI, a technology that can generate text, images, software code and other outputs.
The CDRH’s Digital Health Center of Excellence held two advisory committee meetings on the topic: one in 2024 on how the agency should regulate generative AI, and another last year on digital mental health devices, including chatbots that may or may not be overseen by a clinician.
“We are taking all the feedback that we heard, and I encourage you to look toward the end of this year for some initial thoughts,” Tarver said.
The update provided clarity as the Trump administration has focused on AI adoption and deregulation, but with little information on what that means for healthcare.
Last year, after President Donald Trump was sworn in for his second term, the CDRH issued just one final guidance related to AI, on predetermined change control plans. Meanwhile, the agency grappled with staff cuts, which affected experts in AI and digital health, although some employees were reinstated.
In 2026, the new year started off with two unannounced changes to digital health guidance documents that exempted some types of wellness features and clinical decision support tools from device regulations.
