Articles tagged with “predetermined-change-control-plan”

FDA Generative AI Medical Device Evidence Matrix

A 2026 analyst guide to FDA's GenAI medical device discussion paper, with a two-axis risk matrix, competency evidence plan, lifecycle monitoring controls, and 30/60/90-day readiness actions.

27 min read

9/19/2026

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MedTech AI Quality Benchmark: Validation and PCCPs

A 2026 MedTech AI quality benchmark for clinical validation, PCCP maturity, model traceability, postmarket monitoring, survey methods, and a reproducible FDA appendix.

23 min read

9/19/2026

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FDA AI-Enabled Medical Device Authorization Pathways

A 2026 analyst guide to FDA's 510(k), De Novo, and PMA pathways for AI-enabled medical devices, with a reproducible tabulation of FDA's own device list, PCCP adoption data, and peer-reviewed clinical evidence audits.

29 min read

9/5/2026

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FDA-Approved AI Medical Devices List: Complete 2026 Guide

A 2026 guide to the FDA's AI-Enabled Medical Device List: 1,614 entries as of the September 2026 update, 510(k) versus De Novo pathways, radiology's 76 percent share, JAMA Health Forum evidence gaps, and landmark clearances including LumineticsCore and Aidoc CARE.

35 min read

7/19/2026

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FDA Clears First LLM as a Medical Device: Inside UpDoc's 510(k)

Analysis of FDA's December 2025 clearance of UpDoc K253281, the first SaMD using patient-facing LLMs in 2026, covering its 510(k) predicate strategy, PCCP, and data on 1,451 AI device clearances.

35 min read

7/4/2026

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