FDA AI-Enabled Medical Devices List
- Publisher: US Food & Drug Administration (FDA)
- Status:
active - Version:
2025 - Release Date:
2025-12-05 - Date Added:
2025-12-12 - Source URL: www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
Summary
The FDA's AI-Enabled Medican Devices List is an official resource identifying medical devices incorporating artificial intelligence that have been authorized for marketing in the US. The list provides transparency into which devices use AI technologies, outlines the regulatory expectations for safety and effectiveness, and helps innovators understand current trend in AI-driven clinical tools. It also supports healthcare providers and patients in recognizing when AI is present in devices they use.
Key Takeaways
- Lists AI-enabled medical devices that have met FDA premarket safety and effectiveness requirements
- Provides direct links to FDA device summaries for tranparency and public understanding
- Helps innovators understand regulatory expectations and current AI medical device trends
Additional Sources
Tags
ai, medical-devices, regulation, safety, healthcare, llm, transparency, appsec,
License
Public-domain