What is 21 CFR Part 820? How does this impact your Medical Device in US.

What is 21 CFR Part 820?
Today, we're exploring the critical steps manufacturers must take to ensure their products meet the highest standards of safety and effectiveness. Let's unravel 21 CFR Part 820 and how it shapes the Quality Management Systems in the US. Check our article here:matrixreq.com/...
Recently the FDA has issued a final rule to adopt ISO 13485 into it’s quality system regulation.
This aligns expectations of Quality Management Systems between the US and Europe.
However, for those of you interested in the European market, even with these aligned expectations, you will need to abide by ISO 13485.
Part 1:
21 CFR Part 820 stands for Part 820 of Title 21 of the Code of Federal Regulations.
Established by the FDA, these regulations set the foundation for good manufacturing practices focusing on Quality Management Systems, or QMS. Since December 1978, it's aimed to ensure that medical devices in the US market are safe, effective, and compliant. Check our article on Design History File here: matrixreq.com/...
21 CFR Part 820 requires manufacturers to develop a structured, process-based QMS.
This legal framework ensures that every aspect of production meets regulatory and customer requirements, from design to distribution.
21 CFR Part 820 is divided into 15 subparts, each addressing a specific aspect of the Quality System. Let's briefly go over these:
General Provisions: Defines the scope and applicability, emphasizing its relevance to manufacturers of finished devices.
Quality System Requirements: Outlines management responsibilities, audit, and training needs.
Design Controls: Focuses on procedures and controls throughout the design cycle.
Document Controls: Ensures proper document management for accessibility and security.
Purchasing Controls: Deals with supplier management and purchasing processes.
Identification and Traceability: Ensures clear product identification through all stages.
Production and Process Controls: Covers various aspects of production and process management.
Acceptance Activities: Describes testing and acceptance criteria.
Non-conforming Product: Details how to handle products that don't meet standards.
Corrective and Preventive Action (CAPA): Guides the CAPA process, from documentation to effectiveness checks.
Labeling and Packaging Control: Ensures label integrity and safe packaging.
Handling, Storage, Distribution, and Installation: Aims to protect product quality post-manufacturing.
Records: Specifies record-keeping requirements for FDA review.
Servicing: Outlines requirements for product servicing.
Statistical Techniques: Describes the use of statistical methods in quality control.
ISO 13485 vs 21 CFR Part 820
While both ISO 13485 and 21 CFR Part 820 focus on Quality Management Systems, they are different animals. ISO 13485 is a global standard, it is not a region specific standard or law, such as 21 CFR Part 820 being a regulation specific to the US.
There are slight differences in documentation, emphasis, and scope. Manufacturers needing to comply with both must carefully align their QMS to meet all requirements. This is something we can help you with here at Matrix Requirements, many of our customers are launching Medical Devices in the US & the EU at the same time.
Implementing a compliant QMS is challenging but crucial.
Choosing a solid solution (Not sure if i’ll mention Matrix here) simplifies this process, offering a platform where teams can collaborate, manage documentation, and ensure compliance with both 21 CFR Part 820 and ISO 13485. It's not just about meeting legal requirements; it's about ensuring the highest quality and safety of medical devices.
With a comprehensive QMS (matrixreq.com/...) , you will ensure the quality, safety, and efficacy of your Medical Device. Learn more about ISO 13485 here: matrixreq.com/...
Feel free to reach out to the team at Matrix Requirements, we’d be happy to help you on your journey as you learn more about your 21 CFR Part 820 or ISO 13485 implementation.
Visit our website to learn more: matrixreq.com/
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