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May 20, 2024 · Navigate the complexities of 21 CFR Part 820 compliance with our comprehensive guide. Learn about the requirements for medical device manufacturers, including quality system regulations, design controls, CAPA, and more.
6 days ago · The term “21 CFR” refers to Title 21 of the Code of Federal Regulations (CFR), a list of operational requirements that an FDA-regulated manufacturing company must comply with to produce and sell products to consumers. You may also hear it referred to as “CFR Title 21.”
May 16, 2024 · Title 21: Food and Drugs. List of Subjects revised as of April 1, 2024. 21 CFR Part 1_General enforcement regulations. Cosmetics. Drugs. Exports. Food labeling.
2 days ago · Recipient Title. CEO. ... Code of Federal Regulations (CFR), Part 820. ... and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices. ...
6 days ago · Key Definitions for Quality System Regulation Under Code of Federal Regulations (CFR) Title 21 Volume 8. 21 CFR 820.3 (k)—Establish—Define, Document and Implement. 21 CFR 820.3(l)—Finished device-any device or accessory to any device suitable for use or capable of functioning, whether or not it is packaged, labelled, or sterilised.
May 16, 2024 · This is a list of Code of Federal Regulations (CFR) Subjects arranged by CFR Title and Part. The files are current as of April 1, 2024.
4 days ago · 21 CFR Part 820: Medical Device cGMP Professional Certification Program. The program aims to deliver a strong understanding of FDA 21 CFR Part 820, and how it applies to the many areas of a medical device manufacturing company.
