Some medical devices that use artificial intelligence to make care decisions can now reach patients before their makers have received marketing authorization, the formal federal clearance that normally must precede any commercial sale of a medical product. The Food and Drug Administration is running this experiment through a pilot called TEMPO, which has accepted four devices so far, including AI products from Cadence and Limbic.
What the TEMPO pilot is and why it exists
Marketing authorization is the FDA's standard gatekeeper step. Without it, a device cannot legally go to market. The TEMPO pilot suspends that requirement for a specific purpose: expanding the pool of technologies available under the Medicare ACCESS model.
The Medicare ACCESS model is a federal experiment in which Medicare pays for digital health tools that help beneficiaries manage chronic conditions. The program needs a meaningful supply of products to operate, and the TEMPO pilot is designed to add to that pool.
Generative AI, in this context, refers to AI that produces outputs such as clinical recommendations or care-related decisions, rather than only returning a fixed binary result. Traditional device regulation was built around products with stable, predictable behavior. A generative system can respond differently to the same inputs, which is why existing frameworks fit this category poorly.
What each side gains from the arrangement
For the FDA, the pilot is a way to observe how these devices actually perform in practice before the agency writes permanent rules. That approach inverts the standard regulatory sequence, which typically demands evidence of safety and effectiveness before any patient exposure takes place.
For companies like Cadence and Limbic, the program opens a path to patients that would otherwise require navigating a regulatory framework the agency hasn't yet completed. The FDA has described the arrangement as an opportunity for both the agency and developers to experiment with AI regulation in the real world.
What has been granted is acceptance into the pilot. The terms for any permanent market authorization come later.