CFR stands for Code of Federal Regulations. Title 21 of CFR covers the broad area of food and drugs, while Part 820 relates to quality systems for medical devices.

Important Update: In February 2026, the FDA is replacing 21 CFR Part 820 with a new Quality Management System regulation (QMSR) that harmonizes with ISO 13485:2016. This represents the most significant update to medical device quality requirements in decades.

The current 21 CFR 820 outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for designing, manufacturing, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe, effective, and are in compliance with the Federal Food, Drug, and Cosmetic Act.

The new QMS regulation maintains these core objectives while introducing a risk-based approach, updated terminology, enhanced documentation requirements, and strengthened supplier management expectations. The transition aligns US requirements with international standards, reducing regulatory burden for companies operating in global markets.

21 CFR 820 is applicable to manufacturers of finished medical devices that are sold in the United States, including foreign manufacturers who import devices. Some medical device manufacturers might be subject only to certain requirements, depending on the operations they are engaged in. The FDA enforces these regulations, and manufacturers must achieve full compliance with the new QMSR by February 2, 2026.