2017 Medical Devices Warning Letters Statistics

In the first half of Fiscal Year 2017 review you could read about the Warning Letters issued to manufacturers of medical devices during 1 October 2016 through 31 March, 2017. Now, the numbers of Medical Device Warning Letters for the entire fiscal year 2017 (1 October 2016 - 30 September 2017) are available.

In the following you will find a comparison with former fiscal year 2016.

The number of Warning Letters issued by the "Center for Devices and Radiological Health" (CDRH) in fiscal year 2017 is decidedly lower than in 2016 (61 warning letters). Out of the 34 Warning Letters issued in 2017, 28 are related to the cGMP regulations for medical devices (Quality System Regulations = QSR) in 21 CFR 820.

Within the top 5, some "old acquaintances" from former years can be found. Holding the 1st place since 2008 are CAPA deficiencies. In 2nd place this time are deficiencies concerning "Complaint Files" (3rd place in 2016). The 3rd place is shared by deficiencies regarding "Design Controls" (2nd place in 2016) and 21 CFR 820.80 (8th place in 2016). In 4th place are deficiencies in "Production Process Controls" (2016: 6th place) and deficiencies concerning "Nonconforming Product" (2016: 7th place). The 5th place went to process validation.

What's also interesting is the allocation of criticised deficiencies to the subparts of 21 CFR 820. Like in 2016, the 1st place was taken by subpart G (("Production and Process Control"). The deficiencies in process validation contribute significantly to this. In 2nd place is subpart M ("Records"), same as in 2016. Also like in 2016, 3rd place was taken by subpart J ("CAPA"). 4th place goes to subpart B ("Quality System Requirements") (6th place in 2016). subpart C ("Design Controls") falls back to 5th place (4th place in 2016).

An elaborate comparison, also including former years, can be found in the table below:

Year Number of WLs Top 1 Top 2 Top 3 Top 4 Top 5
2002 61 100 75 198 30 70
2003 61 100 30 198 20 80
2004 104 100 20 22 30 80
2005 106 100 198 80 20 22
2006 79 100 30 198 80 75
2007 78 30 100 198 70/80 75
2008 91 100 198 30 20 80
2009 84 100 198 30 20 22
2010 182 100/198 30 75 80 20
2011 156 100 30 198 50 75/80
2012 181 100/198 30 80 50 90/184
2013 199 100 198 30 80 50
2014 98 100 198 30 50 80
2015 95 100 198 30 50 75
2016 61 100 30 198 50 75
2017 34 100 198

30/80

70/90 75

WLs: Warning Letters

The table only lists the last part of the CFR regulations.

21 CFR 820.20: Management responsibility
21 CFR 820.22: Quality audit
21 CFR 820.30: Design controls
21 CFR 820.50: Purchasing controls
21 CFR 820.70: Production and Process control21 CFR 820.75: Process validation
21 CFR 820.80: Receiving, in-process, and finished device acceptance
21 CFR 820.90: Nonconforming product
21 CFR 820.100: Corrective and preventive action
21 CFR 820.184: Device History Record
21 CFR 820.198: Complaint files

Conclusion

There's been a notably lower number of Warning Letters for fiscal year 2017. While there were almost 100 Warning Letters issued by the FDA in 2014 and 2015, the number has been decreasing from 61 in 2016 to 34 in fiscal year 2017. The FDA Medical Devices Warning Letter Statistics for 2017 however do not reveal much that is new. The top five deficiencies are the mostly same as in past years; the deficiencies related to "Production and Process Control" (21.CFR 820.70) alone have made it into the top 5 for the first time since 2007. Deficencies regarding Nonconforming Products are new in the top five. In regards to subparts, subpart G ("Production and Process Controls") takes 1st place in 2017. Amongst other reasons, this is once more also due to the findings related to process validation.

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