What is 21 CFR for medical devices?
“21 CFR” means Title 21 of the U.S. Code of Federal Regulations, which contains FDA rules for medical devices, drugs, food, and related products. Medical-device requirements are distributed across multiple parts rather than contained in one single regulation.
Answer
Title 21 CFR converts statutory requirements from laws such as the Federal Food, Drug, and Cosmetic Act into detailed federal regulations. For medical-device companies, the applicable CFR parts depend on the product, establishment activities, marketing pathway, and lifecycle stage.
Frequently referenced provisions include:
• 21 CFR Part 807 for registration, listing, and premarket notification
• 21 CFR Part 820 for medical-device quality management systems
• 21 CFR Part 801 for labeling
• 21 CFR Part 803 for adverse-event reporting
• 21 CFR Part 806 for corrections and removals
• 21 CFR Part 812 for investigational devices used in clinical studies
• 21 CFR Part 814 for PMA, HDE, and associated submissions
• 21 CFR Part 830 for Unique Device Identification
A citation such as “21 CFR 807.20” identifies a particular section within Part 807. The requirements should be read together with the relevant device-classification regulation, FDA guidance, recognized consensus standards, and current agency policy.
A Class I nonsterile device may have a relatively limited compliance profile, while a sterile implantable or software-enabled device may require extensive design, risk-management, clinical, cybersecurity, manufacturing, and post-market controls.
Consequently, saying that a device “complies with 21 CFR” is too broad without identifying the applicable parts and sections. Compliance documentation should map each relevant requirement to company procedures, technical records, and objective evidence.
Trust Our Expert Answers?