Glossary of Terms
21 CFR 820
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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. It outlines Current Good Manufacturing Practice (CGMP) regulations that governs the methods used in, and the facilities and controls used for the designing, manufacturing, packaging, labelling, 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.

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 21 CFR 820 regulations.

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