FDA digital health leader promises generative AI regulatory guidance is coming

August 24, 2026 - 15:42

The U.S. Food and Drug Administration is preparing to release formal guidance on how it will regulate generative artificial intelligence used in medical devices, according to Rick Abramson, the agency's senior digital health policy lead. Speaking at a recent industry conference, Abramson said the FDA recognizes the rapid adoption of tools like large language models and other generative systems in clinical settings, and that the agency is moving to clarify its expectations.

Abramson noted that while the FDA has already approved some AI-enabled devices, generative AI presents unique challenges because it can produce new content rather than simply analyze existing data. This raises questions about validation, transparency, and how to manage risks when the system's output is not fully predictable. The upcoming guidance, he said, will address these issues, including what developers need to show in terms of performance testing and post-market monitoring.

The agency has been under pressure from both industry and healthcare providers to provide clearer rules. Many companies are unsure whether their generative AI products fall under existing device classifications or require new pathways. Abramson acknowledged the uncertainty but stressed that the FDA is committed to a balanced approach, one that encourages innovation while protecting patient safety. He did not give a specific timeline for the guidance's release but said it is a top priority for the digital health office. Stakeholders are watching closely, as the final document could shape the future of AI in medicine for years to come.