FDA Warning Letter Trends for Medical Devices in Fiscal Year 2025

According to ECA Concept Heidelberg’s evaluation of FDA warning letters, 44 warning letters related to medical devices were issued in fiscal year 2025 (1 October 2024 – 30 September 2025), a figure comparable to 2024 (47 letters) but significantly higher than the 11–21 letters recorded in earlier years. Of these, 38 letters (2024: 27) cited violations of the Quality System Regulations (21 CFR 820), marking a notable increase. The most frequent deficiencies involved Corrective and Preventive Actions (CAPA) with 26 cases, followed by design controls (25), complaint files (23), purchasing controls (15), and process validation (14). These categories have consistently ranked among the top issues in recent years. Overall, the 2025 data reflects stable but persistently high regulatory non-compliance levels, highlighting ongoing challenges in quality system adherence. Participants of the upcoming ISO 13485 training in November 2025 will receive the updated Medical Device Warning Letter Navigator.

07-11-2025