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Medical device regulatory insight · 2026-05-14

FDA Leadership Change! New Acting Commissioner Lacks Medical Device Experience

On May 12, 2026, Makary stepped down as FDA Commissioner, and attorney Diamantas is serving as acting commissioner. CDRH layoffs, 510(k) scheduling, and AI device guidance will be affected—must-read for medtech professionals.

FDA Leadership Change! New Acting Commissioner Lacks Medical Device Experience

On May 12, 2026, Makary resigned as FDA Commissioner, with attorney Diamantas serving in an acting capacity. CDRH layoffs, 510(k) scheduling, and AI medical device guidance will be affected, making this essential reading for medical device professionals.