By Adam Atherton, PE, RAC, Principal Engineer, Kymanox Corporation, Morrisville, North Carolina
In 2021, the article, “The Top 10 Most-Cited Clauses In FDA FY2021 Medical Device Inspections,” published in Med Device Online, broke down the most cited Quality System Regulation (QSR) clauses during FY2021, which ran from 01 October 2020 through 30 September 2021. This article explores the inspection findings during FY2022 with a concentration on Design Controls.
Countering the trend of the last few years, the FDA performed substantially more inspections in FY2022 as indicated by the number of Notices of Inspectional Observation (Forms 483 (i.e., 483s)) issued. The number of 483s issued against medical device manufacturers in FY2022 was 538 compared to 191 in FY2021, an increase of almost 200%. The number of 483s issued against medical device manufacturers in FY2020 and FY2019 were 422 and 822, respectively. FY2019 ended on 30 September 2019 so it is a pre-pandemic year.
Similar to previous years, the top three most cited clauses remain Corrective and Preventive Action (CAPA; 21 CFR 820.100), Design Controls (820.30), and Complaints (820.198) at 12.42%, 12.32%, and 10.61% of all cited clauses, respectively. All combined, these three accounted for 35% of all clauses cited in medical device 483s issued in FY2022. A more detailed look into these 483s is provided in this article.