FDA Warning Letter Statistics on Medical Devices in the past Fiscal Year

On behalf of the ECA Concept Heidelberg regularly analyses the deficiencies in FDA Warning Letters regarding medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device (in the US there are other possible combinations), these statistics are also of interest to manufacturers of these products.

In the 2024 fiscal year (1 October 2023 - 30 September 2024), the number of Warning Letters was significantly higher than in the past at 47. Last year, there were a total of 24 Warning Letters (20 of which related to 21 CFR, 820 Quality System Regulations, QSR). In the late 2010s and early 2020s, the number was between 11 and 21 Warning Letters.

Of the total of 47 Warning Letters in the 2024 fiscal year, however, 'only' 27 Warning Letters concerned the Quality System Regulations (21 CFR 820). But that is 7 Warning Letters more relating to the Quality System Regulations than last year. Warning letters relating to misbranded and adulterated products with regard to Covid-19 were generally not included in the statistics.

The statistics for the 2024 fiscal year

To be clear from the beginning, even with the higher number of Warning Letters, the 'frontrunners' are almost the same as in previous years.

• This time, deficiencies relating to design controls (21 CFR 820.30) take first place (21 Warning Letters). Last year, deficiencies relating to design controls were also in 1st place, together with deficiencies relating to CAPA 
• 2nd place (16 Warning Letters) this year is occupied by CAPA deficiencies (1st place last year). 
• Third place (12 Warning Letters) goes to deficiencies relating to 'Complaint Files' (21 CFR 820.198).  Last year, these deficiencies were in 2nd place, together with deficiencies relating to process validation (21 CFR 820.75). 
• Deficiencies relating to 'Purchasing Controls' (21 CFR 820.50) ranked 4th (9 Warning Letters). In 2023, these deficiencies were in 3rd place. 
• This year, 5th place (5 Warning Letters each) is shared by quality audit deficiencies (21 CFR 820.22) and non-conforming product deficiencies (21 CFR 820.90). Quality audit deficiencies also took 5th place last year, while non-conforming product deficiencies were listed in 6th place.  

Conclusion

In fiscal year 2024, there is a strikingly high number of Warning Letters to medical device manufacturers compared to previous years. This also makes a statistical analysis easier, as the 'selectivity' in the ranking becomes clearer. However, the top 5 once again includes 'old acquaintances' who have been in the top 5 in a similar way in previous years.

Participants in the training Combination Products on 11/12 February 2025 in Heidelberg, Germany, will receive the Medical Device Warning Letter Navigator with all Warning Letters to medical device manufacturers and their statistical evaluation since 2002.