The classification order
21 CFR 892.2055 (effective June 17, 2026): radiological ML imaging software → Class II with four special controls.
Free field guide · PDF
FDA AI/ML: Medical Device2026 Field Guide
The classification order, the PCCP, and the global picture — with the AI-device practice you need.
- 892.2055 live
- Jun 2026
- PCCP law
- §515C
- Devices
- 1,000+
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The PCCP
The four PCCP elements under FDORA §515C: planned modifications, modification protocol, and impact assessment.
The global picture
Health Canada's April 2026 MLMD guidance, the UK's 2027 PCCP target, and the 1,000+ authorized devices.
Sources & scope
- iso13485expert.com, FDA Classifies AI Imaging Software Under 21 CFR 892.2055 (Sep 2026).
- meddeviceguide.com, Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model.
- auroratic.com, FDA's Predetermined Change Control Plan (2026).
This guide is market-access intelligence, not regulatory or legal advice. FDA AI/ML expectations, PCCP practice, and international change-control rules change — professional review is required before business use.
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