FDA Warning Letter Statistics on Medical Devices in the Past Fiscal Year 2025

Concept Heidelberg regularly evaluates the deficiencies in FDA warning letters concerning medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device (there are other combination possibilities in the USA), these statistics are also of interest to manufacturers of these products.

In fiscal year 2025 (1 October 2024 - 30 September 2025), the number of Warning Letters was 44, which is roughly comparable to last year's figure (47).  In the late 2010s and early 2020s, the number ranged between 11 and 21 Warning Letters.

However, of the total 44 Warning Letters in fiscal year 2025, 38 (2024: 27) concerned the Quality System Regulations (21 CFR 820). But that is 11 more Warning Letters related to the Quality System Regulations than last year.

Statistics for the 2025 fiscal year

To get straight to the point, the 'frontrunners' are almost the same as in previous years.

First place (26 Warning Letters) this time goes to deficiencies in CAPA (last year in second place). Conversely, deficiencies in design controls (21 CFR 820.30) are in second place this year (last year in first place) with 25 deficiencies. Third place (23 Warning Letters) goes, as last year, to deficiencies in Complaint Files (21 CFR 820.198).  Fourth place (15 Warning Letters) goes to deficiencies in purchasing controls (21 CFR 820.50), also as in 2024. And fifth place, with 14 Warning Letters, goes to deficiencies in process validation (21 CFR 820.75). In 2024, process validation was in second place. 

Conclusion

In fiscal year 2025, there are a similar number of Warning Letters sent to medical device manufacturers as in 2024 - and significantly more than in previous years. This also makes statistical analysis easier, as the 'selectivity' in the ranking becomes clearer. However, the top 5 again includes 'old acquaintances' that have been in the top 5 in recent years.

Participants in the Live Online Training "ISO 13485 Requirements for Medical Devices' on 25/26 November 2025 will receive the Medical Device Warning Letter Navigator with all Warning Letters to medical device manufacturers and their statistical analysis since 2002.