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RegWatchDaily — Tuesday Brief
RegWatchDailyApr 7 · 4 min read

⚠ Warning Letter

Cardinal Health receives WL for CAPA deficiencies — 4 citations under 820.100

What they missed and how to audit-proof your own CAPA system →

📋 510(k) Clearance

15 new Class II clearances this week — including 3 AI/ML-enabled devices

📌 Regulatory Update

FDA finalizes QMSR implementation guidance — key changes from Part 820

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