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FDA

The FDA is the U.S. agency that regulates drugs, medical devices, food safety and tobacco products. In August 2026 it sought feedback on how to regulate medical devices built on generative AI.

Researched and fact-checked by AI, with no human review. 17 sources listed below. How we verify

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What the FDA does

The U.S. Food and Drug Administration (FDA) is an agency within the Department of Health and Human Services, its press releases say. Its stated responsibilities include ensuring the safety, efficacy and security of:

  • human and veterinary drugs
  • biological products
  • medical devices

It also oversees the safety of the food supply, cosmetics and products that emit radiation. It regulates tobacco products too. Its White Oak campus in Silver Spring, Maryland, was planned to bring its headquarters programs together.

The agency was not known by its present name until 1930, its history page says. Its modern regulatory role began with the 1906 Pure Food and Drugs Act. That law banned interstate commerce in adulterated and misbranded food and drugs. The FDA's milestones timeline says the Medical Device Amendments passed in 1976. Under them, some devices must have FDA approval before they are marketed.

How it oversees AI in medical devices

Devices fall under the FDA's Center for Devices and Radiological Health (CDRH). Its director is Michelle Tarver, the FDA said in August 2026. Within CDRH, the Digital Health Center of Excellence coordinates digital health work across the agency. It supports reviews of digital health technology but does not make marketing authorization decisions.

The FDA keeps a list of AI-enabled devices authorized for marketing in the United States. It says the list is not comprehensive. In October 2026, the newest entries had final decision dates of June 29, 2026. The agency says it will explore ways to tag devices that use foundation models, including large language models. In January 2025, an FDA official said the agency had authorized more than 1,000 AI-enabled devices.

Two guidance documents set out FDA recommendations for AI devices. Final guidance announced in December 2024 covers predetermined change control plans. Such a plan describes planned changes to a device in advance. A January 2025 draft covers the whole life cycle of AI-enabled devices. Its guidance page still marked it as a draft in October 2026.

The FDA uses AI itself. On June 2, 2025, it launched Elsa, a generative AI tool powered by a large language model. The agency said Elsa was designed to help staff with reading, writing and summarizing.

What is it asking about generative AI devices?

On August 18, 2026, the FDA issued a discussion paper on regulating medical devices that use generative AI. The paper says it is for discussion only and is not draft or final guidance. It outlines a possible two-axis framework for judging risk. It also describes testing inspired, at a high level, by how doctors are trained and evaluated. Feedback is due by October 19, 2026, under docket FDA-2026-N-7874. A news report covers the paper. The AI in Medicine Regulation Tracker follows the FDA's steps on medical AI.

What to watch

  • Leadership. Kyle A. Diamantas has been acting commissioner since May 2026, when Martin Makary resigned, Healthcare Dive reported. President Trump nominated Heidi Overton in August 2026. On October 2, RAPS reported, citing STAT, that she would not get a Senate vote until after November 9.
  • Work with the UK. The MHRA, the UK's medicines and devices regulator, says in its 2030 strategy explainer that it will work with the FDA to explore mutual recognition for medical devices.
  • Next steps on generative AI. The paper says comments may inform further policy. It gives no timeline.

FDA timeline

  1. The FDA issues a discussion paper on regulating generative AI-enabled medical devices and asks for feedback by October 19, 2026.

    Source: U.S. Food and Drug Administration

  2. Commissioner Martin Makary resigns, and Kyle Diamantas becomes the FDA's acting leader.

    Source: Healthcare Dive

  3. The FDA launches Elsa, a generative AI tool powered by a large language model, to help its staff with reading, writing and summarizing.

    Source: U.S. Food and Drug Administration

  4. The FDA issues draft guidance with recommendations for AI-enabled devices across their total product life cycle.

    Source: U.S. Food and Drug Administration

  5. The FDA announces final guidance on predetermined change control plans for AI-enabled device software functions.

    Source: U.S. Government Publishing Office (govinfo)

  6. The Medical Device Amendments pass, requiring some medical devices to have FDA approval before they are marketed.

    Source: U.S. Food and Drug Administration

  7. The Food, Drug, and Insecticide Administration's name is shortened to Food and Drug Administration.

    Source: U.S. Food and Drug Administration

  8. Congress passes the original Food and Drugs Act, which bans interstate commerce in misbranded and adulterated foods, drinks and drugs.

    Source: U.S. Food and Drug Administration

Sources

  1. What We Do, U.S. Food and Drug Administration
  2. FDA History, U.S. Food and Drug Administration
  3. Milestones in U.S. Food and Drug Law, U.S. Food and Drug Administration
  4. White Oak Campus Information, U.S. Food and Drug Administration
  5. FDA Commissioner, U.S. Food and Drug Administration
  6. FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices, U.S. Food and Drug Administration
  7. Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, U.S. Food and Drug Administration
  8. Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback (PDF), U.S. Food and Drug Administration
  9. About the Digital Health Center of Excellence, U.S. Food and Drug Administration
  10. List of Artificial Intelligence-Enabled Medical Devices, U.S. Food and Drug Administration
  11. FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices, U.S. Food and Drug Administration
  12. Federal Register, Volume 89 Issue 233 (Wednesday, December 4, 2024), U.S. Government Publishing Office (govinfo)
  13. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, U.S. Food and Drug Administration
  14. FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People, U.S. Food and Drug Administration
  15. FDA nominee Overton parries vaccine questions at Senate hearing, Healthcare Dive
  16. This Week at FDA: No Overton vote until after midterms, FDA signals advisory committee support, and more, Regulatory Affairs Professionals Society (RAPS)
  17. MHRA Strategy to 2030: What it means for MedTech, Medicines and Healthcare products Regulatory Agency (GOV.UK)

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