Frequently Asked Questions: FDA 21 CFR Part 820
What is 21 CFR Part 820?
21 CFR Part 820 is a quality system regulation enforced by the U.S. Food and Drug Administration (FDA) with the goal of ensuring that medical devices are safe and effective for their intended use. The regulation is part of current Good Manufacturing Practice (cGMP) requirements for medical device manufacturers. Compliance with the regulation is required to market and distribute medical devices in the United States.
Why is 21 CFR Part 820 important?
21 CFR Part 820 is important to medical device manufacturers working in the United States since compliance with the regulation is mandatory. Demonstrating compliance proves to the FDA, customers and the public that your company embraces quality processes and can reliably deliver medical devices that work as purported.
What are the requirements of FDA 21 CFR Part 820?
FDA 21 CFR Part 820 has 15 subparts labeled alphabetically. They are:
- General provisions
- Quality system requirements
- Design controls
- Document controls
- Purchasing controls
- Identification and traceability
- Production and process controls
- Acceptance (inspections and validations)
- Nonconforming product
- Corrective and preventive actions (CAPA)
- Labeling and packaging controls
- Handling, storage, distribution and installation
- Records
- Servicing
- Statistical techniques
What is the difference between FDA 21 CFR Part 820 and ISO 13485?
FDA 21 CFR Part 820 is a national regulatory standard enforced in the United States, while ISO 13485 is an international standard outlining medical device quality management criteria. ISO 13485 is not mandatory in the United States, however it is the main quality guideline for several other countries, including much of Europe, Canada, Japan and Australia.
Outside of jurisdiction, the main difference between 21 CFR 820 and ISO 13485 is that ISO 13485 more completely follows a risk-based approach.
In January 2024, the FDA published a final rule amending 21 CFR Part 820. The change will officially bring FDA med device quality requirements more in line with ISO 13485. The revised part 820 is referred to as the Quality Management System Regulation (QMSR) and is scheduled to go into effect on February 2, 2026.
How does QT9 QMS help meet and maintain 21 CFR Part 820 compliance?
QT9 QMS is a highly rated quality management solution geared toward regulatory compliance and efficient systems. We offer more than 23 modules that come standard, including Document Control, Audit Management, Nonconforming Products, Corrective Actions, Employee Training and Customer Feedback, as well as a Device History Record integration.
2024 will also see the release of our all-new Design History File application. All can help medical device manufacturers address FDA 21 CFR Part 820 and other regulations, such as ISO 13485.
Our QMS is backed by free software updates, full customer support, an available ERP integration and Business Intelligence tool. Call today for more information.
