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

Randy Anderson; Christabel Tan

doi:10.37421/2167-7689.2023.12.397

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

Randy Anderson, Christabel Tan

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English
Article number	397
Pages (from-to)	1-4
Number of pages	4
Journal	Pharmaceutical Regulatory Affairs: Open Access
Volume	12
Issue number	6
DOIs	https://doi.org/10.37421/2167-7689.2023.12.397
Publication status	Published - 8 Nov 2023

Keywords

CAPA

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© 2023 Anderson R, et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/
Final published version, 80.6 KBLicence: CC BY

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Cite this

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

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