The QMSR change
QMSR took effect 2 February 2026: ISO 13485:2016 is now effectively law for FDA-regulated devices — IEC 62304 governs the software.
Free field guide · PDF
AI / SaMD Medical Device Regulation2026 Field Guide
The QMSR change, the PCCP lever, and the EU AI Act overlap — with the AI-SaMD practice you need.
- FDA QMSR effective
- 2 Feb 2026
- AI/ML devices cleared
- 1,016+
- PCCP final guidance
- Dec 2024
Sourced from regulatory guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — regulatory guidance and verified 2026 publications.
The PCCP lever
PCCPs let AI/ML devices ship pre-approved model updates without a new submission — but only 16.7% of 2024 devices used them.
The CDS line and EU overlap
The Jan 2026 CDS update widens the non-device line, cybersecurity gates premarket review, and the EU AI Act stacks on top of MDR.
Sources & scope
- intuitionlabs.ai, An Introduction to Software as a Medical Device (SaMD).
- github.com/jcafazzo/samd-qms-workflow, regulatory landscape (Feb 2026).
- mindbowser.com, FDA Requirements for RPM Software Devices in 2026.
This guide is market-access intelligence, not regulatory or legal advice. AI-SaMD rules, guidance, and review practice change — professional review is required before business use.
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AI/SaMD on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your AI-SaMD route — QMSR readiness, PCCP planning, and multi-market pathway mapping.
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