Rick Abramson, Director of the Digital Center of Excellence at the U.S. Food and Drug Administration (FDA), confirmed that formulating regulatory policies specifically for generative AI is a top priority reaching the highest levels of the White House and the Secretary's office, noting expectations that draft guidance will be issued within the next few months.
These remarks came during the Medical Technology Conference in Boston, coinciding with the closing of the public comment period on a discussion paper published by the agency regarding regulatory frameworks for generative AI, which focused heavily on enhancing post-market surveillance. The agency received more than 500 comments and submissions from stakeholders.
Agency Regulatory Priorities
Abramson explained that the discussion paper is not merely an academic or intellectual exercise, but the agency intends to turn it into actual policies soon. The agency's regulatory priorities list for fiscal year 2027 includes two main drafts:
- Draft Guidance on AI-Enabled Devices for Mental Health Disorders: This is a direct result of last year's Digital Health Advisory Committee meetings held to discuss mental health chatbots.
- Draft Guidance on Risk Assessment and Evidence Generation: This serves as a comprehensive guiding framework for devices relying on generative AI.
In addition, the agency is finalizing the management of the AI lifecycle, drafted in early 2025, which targets devices with more locked-in models.
Regulatory Updates in the United Kingdom
Following in the footsteps of its American counterpart, Jessica Paulsen, Deputy Director of AI and Software at the UK Medicines and Healthcare products Regulatory Agency (MHRA), provided similar regulatory updates. The British agency recently adopted 44 recommendations submitted by an independent committee on AI regulation in healthcare.
Some of these directions align with the American approach, particularly regarding the necessity of monitoring the performance of devices using generative AI over time, rather than relying excessively on one-time evaluations that may not reflect actual performance in changing real-world conditions.
Why This News Matters
This development represents a pivotal step toward establishing long-term regulatory rules governing the use of AI and generative AI in the healthcare and medical device sectors. Given that technological models are constantly evolving, establishing clear frameworks for post-market surveillance and risk assessment contributes to patient protection and ensures the reliability of these advanced technologies in clinical environments, alongside enhancing international regulatory cooperation between the United States and Britain.