AI in Medicine News ・ ⚖️ Device approvals and regulation

FDA warning letters rarely mention AI, retrospective analysis finds

Bioengineer.org 🔗 Share link 11/04 10:32 UTC 🔗 Share link What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI — Bioprocess Online · 11/04 07:06 UTC

A retrospective analysis of 3,011 FDA warning letters issued from January 2022 to September 2026 found that only seven, or 0.23 percent, referred to artificial intelligence.

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