FDA approves pilot tests for generative AI devices
What the FDA's TEMPO pilot allows, what it doesn't, and why access through a pilot is not the same as approval.
Glossary
- Medical device (FDA definition)
- Under section 201(h) of the Federal Food, Drug, and Cosmetic Act: an instrument, apparatus, machine, implant or similar article used to diagnose, treat, cure or prevent disease, or to affect the structure or function of the body, without relying on chemical action or metabolism.
- FDA — How to determine if your product is a medical device
- Generative AI-enabled medical device (FDA definition)
- A device, meeting the definition above, in which generative artificial intelligence methods or models are integral to the device's output or functionality.
- FDA discussion paper
- Pilot deployment
- A small-scale, controlled test of a new system, product or process in a real environment (a limited group, department or location) before it is available to the public at large. It aims to validate how it works, find where it can improve, and confirm that workflows perform correctly under real-world conditions.
- Hyperbots glossary
- Centers for Medicare & Medicaid Services (CMS)
- A federal agency within the US Department of Health and Human Services. It runs Medicare (for people aged 65 and over, and some younger people with certain disabilities), Medicaid (for lower-income individuals and families) and the Children's Health Insurance Program (CHIP, low-cost cover for children in families earning above the Medicaid threshold), and oversees the insurance exchanges created under the Affordable Care Act.
- CMS — History
- Center for Medicare and Medicaid Innovation (CMMI)
- The US federal healthcare testing laboratory working under CMS. It designs, tests and evaluates new healthcare payment and delivery models intended to lower spending on Medicare, Medicaid and CHIP.
- Wikipedia — Center for Medicare and Medicaid Innovation
- TEMPO pilot
- A pilot launched by the FDA alongside the CMS Innovation Center's ACCESS model (Advancing Chronic Care with Effective, Scalable Solutions). It aims to speed patient access to digital health tools and software as a medical device, allowing them to be used in real-world clinical care before full FDA authorisation.
- FDA — TEMPO press announcement
What the pilot changes
Marketing authorisation usually comes before a medical device is deployed. Think of it as a level of assurance before anything reaches the public. The TEMPO pilot allows selected digital and generative AI devices to be offered within the CMMI ACCESS programme without that authorisation.
The FDA has stated that device effectiveness for the pilot's intended uses has not yet been evaluated. Access is therefore not an effectiveness verdict, and we don't yet know what happens to those devices once the pilot ends.
Alongside the pilot, the FDA has published a discussion paper on generative AI-enabled devices, and is taking comments until 19 October 2026 on competency assessment, postmarket monitoring, foundation models and agentic systems.
Further terms
- Marketing authorisation
- The usual FDA go-ahead needed before a device can be marketed for a use.
- Enforcement discretion
- The FDA chooses not to enforce the usual marketing-authorisation requirement in this pilot setting.
- TEMPO
- An FDA pilot for selected digital health devices, including some generative AI tools.
- CMMI ACCESS
- The care and payment programme in which the selected pilot devices can be offered.
- Foundation models
- Large, general AI models that many applications can be built on top of.
- Agentic systems
- AI that can take multi-step actions towards a goal, not just answer one prompt.
- Postmarket monitoring
- Watching how a device behaves after it is already in use.