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Managing Nonconforming Products under FDA Quality System Regulation (QSR)


The FDA's Quality System Regulation (QSR) serves as a cornerstone for ensuring the safety and efficacy of medical devices. Within this framework, Section 820.90 addresses the crucial control of nonconforming products, emphasizing the significance of maintaining a robust quality management system.

Understanding Nonconforming Products:

Nonconforming products are those that deviate from specified requirements or fail to meet approved specifications. Identifying and managing such products is pivotal in upholding product safety, efficacy, and regulatory compliance.

Challenges and Difficulties in Compliance:

Complying with Sec. 820.90 presents several challenges for medical device manufacturers. These difficulties include accurately identifying and documenting nonconforming products, evaluating their impact, deciding on proper disposition, maintaining compliance with the

Device History Record (DHR), and ensuring timely notification and communication for effective resolution.

Innovative Industry Approaches:

To overcome these challenges, medical device manufacturers employ various innovative strategies and best practices. Robust quality management systems facilitate proactive identification and resolution of nonconformities, while comprehensive employee training fosters a culture of compliance and continuous improvement.

Embracing Technological Advancements:

Leveraging advanced technologies and process automation optimizes the identification and documentation of nonconforming products, enhancing data accuracy and accessibility.

Moreover, fostering a collaborative work environment and open lines of communication enables cross-functional teams to collaborate seamlessly in resolving nonconformance incidents promptly and efficiently.


In navigating the complexities of managing nonconforming products under Sec. 820.90, adopting robust quality management systems, investing in employee training, and embracing technological advancements are critical steps for ensuring regulatory compliance and product quality.

Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.

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