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

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: 1,524 entries reviewed this session, 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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