FDA Classifies AI Radiology Tools for Safer Innovation
Published Date: 6/13/2025
Rule
Summary
The FDA is officially putting radiology computer-assisted detection and diagnosis software into a special safety group called Class II. This means the software will have clear safety rules to follow, making it safer and easier for patients to get new, helpful tech. Companies making this software should get ready for these changes, which aim to speed up innovation without extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Radiology AI Moved to Class II
If you get radiology tests that use computer-assisted detection and diagnosis software, the FDA is officially placing that software into Class II with special safety controls. The FDA says this classification provides a reasonable assurance of safety and effectiveness and should help patients get safe, innovative devices.
New Special Controls for Makers
If you make radiological computer-assisted detection and diagnosis software, the FDA will codify special controls for that device type under Class II. The agency says the action is intended to reduce regulatory burdens and enhance innovation and patient access, so manufacturers should prepare to follow the new codified controls.
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Key Dates
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