The Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections

By Adam Atherton, CRE, Consultant, Product Development, Kymanox Corporation

The Food and Drug Administration (FDA) has intensified its oversight of medical device manufacturers, as evidenced by a significant increase in inspections and citations issued during Fiscal Year (FY) 2023. This article delves into the findings of these inspections, highlighting the most commonly cited deficiencies and underlining the growing emphasis on robust Design Controls.

The analysis exposes a persistent trend – a lack of well-defined and documented procedures. This fundamental shortcoming plagued nearly 60% of citations within the top 10 most frequently violated clauses of the Quality System Regulation (QSR). While Corrective and Preventive Action (CAPA) and Complaint Handling remain areas requiring improvement, Design Controls have emerged as a focal point for the FDA.

Within Design Controls, Design Validation and Design Change citations topped the list. This indicates a potential vulnerability in ensuring medical devices meet their intended use and user needs. Notably, the article underscores the importance of risk management, a crucial aspect often inadequately addressed within the QSR itself. Alternative standards, such as ISO 13485:2016, provide a more comprehensive framework for managing risk throughout the entire product lifecycle.

By proactively addressing these recurring deficiencies, particularly in Design Controls and risk management, manufacturers can not only ensure compliance with FDA regulations but also prioritize patient safety and device effectiveness.