A regulator, not a model developer
The US Food and Drug Administration regulates medical devices, drugs, biological products and other product categories. Its relevance to AI includes decisions about software used in healthcare and methods used to develop medicines. These responsibilities do not make every healthcare AI product FDA-authorized. [1]
Clearing a specific medical-device use
The Tempus ECG-AF decision was a 510(k) substantial-equivalence determination for specified indications. The documentation describes risk notification and follow-up in an eligible population, with limits on using results to direct therapy. [2][3]
Qualifying a tool for drug development
FDA’s AIM-NASH qualification addressed liver-histology scoring in MASH trials. Pathologists retain final interpretation. This pathway qualifies a development tool for a defined context; it does not approve a drug or give the model unrestricted diagnostic authority. [4]
Sources
- What We Do
FDA · retrieved Oct 23, 2026
- 510(k) Premarket Notification
FDA · Jun 21, 2024
- Tempus ECG-AF: 510(k) clearance letter and indications for use
FDA · Jun 21, 2024
- FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials
FDA · Dec 8, 2025