21 CFR Part 820, also known as the Quality System Regulation (QSR), outlines the requirements for the quality systems used in the design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices intended for human use in the United States. All manufacturers of medical devices intended for sale in the United States must comply with 21 CFR Part 820 to ensure their products are consistently produced and controlled according to quality standards. The U.S. Food and Drug Administration enforces compliance with 21 CFR Part 820.
Both 21 CFR Part 820 and ISO 13485 outline standards for a quality management system (QMS) for medical devices. However, 21 CFR Part 820 is specific to the U.S., while ISO 13485 is an international standard. There are similarities and differences, but compliance with one does not guarantee compliance with the other. It is crucial to be aware, however, that the FDA has initiated amendments to 21 CFR Part 820 that will harmonize it with ISO 13485. The final rule outlining the revised requirements, known as the Quality Management System Regulation (QMSR), was published in January 2024.
Design controls are a critical part of 21 CFR Part 820 and involve a systematic approach to the development process, including planning, design inputs, design outputs, design review, design verification, design validation, design transfer, and design changes.
CAPA is a crucial aspect of quality management that requires manufacturers to identify, document, and eliminate causes of nonconformities or potential nonconformities to prevent their recurrence. It involves systematic steps for rectifying issues, improving product quality, ensuring compliance, and fostering continuous improvement.
Yes, the FDA may update regulations to reflect new medical developments, technology advances, or safety information. To ensure ongoing compliance, manufacturers must stay informed about any changes, such as the initiative to harmonize the regulation with the ISO 13485 standard.
Inspection preparation should include ensuring that all aspects of the quality system are in line with Part 820 requirements, conducting internal audits toward those ends, appropriately training employees, reviewing, and updating essential documentation auditors may ask for, and fixing any identified gaps or deficiencies in the quality system.