Notably low number of warning letters issued to device manufacturers in first half of fiscal year 2018

Recommendation

22/23 May 2024

Ongoing/Continued Process Verification - Live Online Training
from Control Strategy to Product Quality Review

The first half of the 2017 fiscal year evaluation of warning letters regarding medical devices was introduced as follows: "Remarkable is the low number of Warning Letters to medical devices manufacturers in the first half of fiscal year 2017 (1 October 2016 - 31 March 2017)". This is also evident in the first half of fiscal year 2018 (1 October 2017 - 31 March 2018). Below you will find an analysis of the top three.

There were slightly more warning letters in this half-year period (18) than during the same period in 2017 (11), although four of those 18 warning letters were not related to medical device GMP (21 CFR 820, QSR). During the comparable period of 2016, there had already been 37 warning letters, whereas 33 had been related to 21 CFR 820 back then.

With overall 14 warning letters, a truly informative statistical evaluation of the top 5 defects is hardly possible; therefore, the focus will be on the top 3 defects this time. This time, defects in connection with Design Controls (21 CFR 30) and Complaint Files (21 CFR 820.198) come in first place. The usual "frontrunner" CAPA deficiencies (21 CFR 820.100) occupies position 2 this time. The third place is also shared by Production and Process Control (21 CFR 820.70) and Device History Record (21 CFR 820.184).

After the low number of warning letters in the first half of fiscal year 2017, the FDA issued more warning letters once more in the comparable period of 2018. It will be interesting to see how this development will continue in the second half of the year. We will keep you informed.