FDA sets Class II special controls for ML imaging software with change plans

What changed

FDA classified radiological machine learning-based quantitative imaging software with a predetermined change control plan into Class II, with special controls identified in this classification order.

Who this touches

Medical device makers building radiological ML imaging tools with predetermined change control plans, and the providers who deploy them.

Why it matters

The special controls named in this order now define what such a device type must meet for market clearance, including how it documents adaptive changes.

Suggested next step — and why

Device makers may want to check the special controls in this order against how their own change control plans are documented.

The clock

Classification order now in effect; no separate compliance date specified in the source.

The editor's read

The special controls don't just describe the device — they define what a predetermined change control plan must document to earn Class II status. A model update you can't trace back to that plan might as well not exist. — IDV