Industry Trends
FDA Enforcement Trends for Medical Devices
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Most-Cited Quality System Categories
54 letters in FY2025, up 38% from FY2024. CAPA led design controls by one letter in both FY2025 and FY2026. Seven post-QMSR letters cite ISO 13485 clauses by number.
Read the Full BreakdownThe Escalation Rate Is Rising
791 Form 483s were issued in FY2025, roughly 15 times the number of warning letters that year. The share that escalate to a letter is rising too, not just the raw count.
Read the Full BreakdownClass I Device Recalls
137 distinct Class I recall events since July 2025, every one of them firm-initiated rather than FDA-mandated. Just 68 distinct firms account for all of them.
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