CONNECT WITH US
HealthTech

HealthTech

Gen AI policy is a White House priority, CDRH digital health leader says

MedTech Dive logo

Published on

Add as a preferred source on Google
Gen AI policy is a White House priority, CDRH digital health leader says

Rick Abramson, director of the FDA’s Digital Health Center of Excellence, said to expect draft guidance in the coming months.

BOSTON — Rick Abramson, director of the Food and Drug Administration’s Digital Health Center of Excellence, said to expect draft guidance on generative artificial intelligence in the coming months at AdvaMed’s The MedTech Conference on Tuesday.

The comment period closed on Monday for an FDA discussion paper on regulatory approaches to generative AI, including a greater emphasis on postmarket monitoring. As of Tuesday, the agency had received more than 500 submissions.

“This is not just an academic paper. It's not just a thought exercise. We intend to draft policy, and it'll come soon,” Abramson said. “This is a priority at the highest levels of the administration. … I'm talking about the level of the secretary and the White House.”

Abramson didn’t commit to a specific timeline, as the agency needs time to wade through the comments, but he said to expect draft guidance in a matter of months.

On the device center’s list of priority guidances for fiscal 2027, a draft on generative AI-enabled devices for mental disorders appears on the FDA’s “A list,” while another draft on risk assessment and evidence generation for generative AI-enabled devices is under construction.

The former is the direct output of digital health advisory committee meetings last year discussing mental health chatbots, Abramson said, while the latter is more of an “umbrella guidance.”

Another priority for the agency is finalizing the AI lifecycle management guidance that was drafted in early 2025 , Abramson said.


Source link
Related Topics:HealthTech

Disclaimer

We strive to uphold the highest ethical standards in all of our reporting and coverage. We TheMorningPulse.fyi want to be transparent with our readers about any potential conflicts of interest that may arise in our work. It's possible that some of the investors we feature may have connections to other businesses, including competitors or companies we write about. However, we want to assure our readers that this will not have any impact on the integrity or impartiality of our reporting. We are committed to delivering accurate, unbiased news and information to our audience, and we will continue to uphold our ethics and principles in all of our work. Thank you for your trust and support.