药品监管事务：开放获取

FDA Medical Device Warning Letters and Trends Pre and Post COVID 2013-2022

Abstract

Randy Anderson and Christabel Tan

The United States Food & Drug Administration requires under Title 21 of the Code of Federal Regulations (21 CFR) Part 820.100, that medical device manufacturers must establish a system to address Corrective And Preventive Actions (CAPAs) to meet regulatory standards. This article provides insight into medical device quality issues relating to CAPA through the evaluation of warning letters issued by the US Food and Drug Administration (FDA) between 2013 and 2022. The results of this study indicate that despite the medical device regulations being in place since 1976 violations of 21 CFR 820.100 (CAPA related violations) continues to be a significant issue for medical device companies.