AMA Outlines Path Forward for FDA Oversight of Generative AI in Medicine

Calls for oversight based on risk that protects patients while supporting the safe development of new medical devices

October 19, 2026 – As generative artificial intelligence (genAI) becomes better at performing medical tasks, the American Medical Association (AMA) has made recommendations to help the U.S. Food and Drug Administration (FDA) update how it tests, regulates, and monitors these technologies when they are used to care for patients.

In a letter to Rick Abramson, MD, director of the FDA’s Digital Health Center of Excellence, the AMA answered the agency’s request for comments on its August 18 discussion paper about regulating medical devices that use genAI. The AMA suggested ways to test how well genAI works in real medical settings, improve monitoring after devices are released, and involve doctors in deciding what level of care is acceptable.

The AMA highlighted two main principles:

• Making rules more flexible must not reduce safety or effectiveness. As genAI changes, it may need new ways of being tested. But flexible rules must still allow the FDA to make sure there is reasonable evidence that devices are safe and effective. Oversight should consider what a device is meant to do, how much harm it could cause, and how well it works throughout its life, including after it is put into use.
• Doctors should help set standards, but they should not have to make up for unsafe technology. Doctors should help develop testing rules and standards for clinical performance. Their knowledge can help identify risks and judge whether a device is useful in medical care. However, doctors watching over a device cannot replace strong evidence that it works safely and reliably in the setting where it is meant to be used. The AMA has offered to work with the FDA and other groups to develop best practices for doctors reviewing AI decisions, checking performance over time, and identifying AI failures that could seriously affect patient care.

“GenAI has the potential to extend the reach of physicians and fundamentally improve how patients receive care. Realizing that potential requires new approaches to evaluating technologies that can perform increasingly consequential clinical functions,” said AMA President Willie Underwood, MD, MSc, MPH. “Physicians have a critical role in defining what good performance looks like, and the AMA is ready to help build the evidence and oversight frameworks that will allow trustworthy AI that improves care. Manufacturers must remain accountable for the performance of their products, and patients and physicians deserve the confidence that these technologies are safe and effective.”

The AMA continues to support an approach to FDA oversight that places as little unnecessary burden as possible on developers while basing the level of oversight on risk. This approach should protect patients and allow new ideas to keep developing. The AMA’s recommendations stress the need for strong clinical evidence, suitable safety measures, and continued checks on performance as genAI technologies change.

The AMA looks forward to continuing to work with the FDA, technology developers, and other groups to support responsible innovation that improves patient outcomes. To learn more about the AMA’s work on rules for responsibility, medical licensing, and regulation as increasingly capable AI takes on medical tasks, visit the AMA’s governance framework for agentic AI.

About the AMA
The American Medical Association supports doctors in caring for patients. It brings together more than 190 state and specialty medical societies, along with other important groups, and speaks for doctors to key people and organizations across healthcare. The AMA works to remove barriers that make patient care harder, prevent long-term diseases, respond to major public health problems, and help shape the future of medicine by addressing healthcare’s biggest challenges. For more information, visit ama-assn.org.