FDA sets Class II special controls for ML imaging software

What changed

FDA finalized an order classifying radiological machine learning-based quantitative imaging software with a predetermined change control plan (PCCP) as a Class II device, subject to special controls now codified in the order.

Who this touches

Medical device manufacturers building radiological ML-based quantitative imaging tools with PCCPs, and the providers who deploy them.

Why it matters

The special controls are now the enforceable baseline for this device type, not a proposal awaiting comment.

Suggested next step — and why

Manufacturers with PCCP-based imaging products should map their change control documentation against the named special controls with regulatory counsel.

The clock

Classification order is final and in force; no further transition date given.

The editor's read

The special controls turn the PCCP from an internal engineering artifact into a document FDA can demand — a plan that can't be shown might as well not exist. — IDV