Medical Device Warning Letter Statistics for Fiscal Year 2022

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

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

In the comparable period of fiscal years 2017 - 2021 (both October 1 - September 30), we mentioned the relatively low number of Warning Letters. This is also evident in fiscal year 2022 (October 1, 2021 - September 30, 2022). For an explanation why please see the conclusion below.

In fiscal year 2022, the number of Warning Letters was 17, which is within the range of the numbers in the comparable period in 2017 (11), 2018 (18), 2019 (13), 2020 (21), and 2021 (16). Two of these 17 Warning Letters also did not relate to medical device GMP (21 CFR 820, QSR), though. Generally not included were Warning Letters on misbranded and adulterated products with respect to Covid-19.

Fiscal Year 2022 Statistics

With de facto 15 Warning Letters, a really meaningful statistical evaluation of the top 5 deficiencies is hardly possible. For that reason, this time, as in recent years, the focus is again on the top 3 deficiencies. This time, first place is taken by deficiencies relating to CAPA (21 CFR 820.100). Second place is shared by deficiencies related to design controls (21 CFR 820.30) and complaints (21 CFR 820.198). In third place are deficiencies on process validation (21 CFR 820.75) and Nonconforming Products (21 CFR 820.90). 

Conclusion 1

Due to the relatively small number of Warning Letters, a wide-ranging listing of defects is hardly possible. But the top 3 are not unknown FDA "findings." CAPA, the longtime leader, continues to take the top spot in fiscal year 2022. Design deficiencies and deficiencies related to "Complaint Files" have also been in the top 3 and top 5, respectively, in recent years. Deficiencies related to nonconforming products, however, are rarely found in the "top ranks." On the other hand, process validation has also appeared more frequently in the top 5 in the past.

Conclusion 2 - Why are there fewer Warning Letters than in the past?

Why have fewer Warning Letters been issued for years? As recently as the mid-2010s, the number was close to 100 in some cases. Has the medical device industry gotten that much better in recent years? Perhaps yes, but the integrative approach that the FDA has been offering for some time following an inspection is probably also taking hold. What does that mean? The FDA responds directly to the response letter that the inspected firm sends in response to a 483 deficiency letter, and interacts with firms. The authority issues fewer Warning Letters in return. But those Warning Letters still show comparable "findings" as they did in the 2010s. 

Participants of the ECA event "GMP for Medical Devices" November 8-9, 2022 in Munich, Germany will receive the ECA Medical Device Warning Letter Navigator with all Warning Letters to medical device manufacturers and their statistical evaluation since 2002.