Key Parts of 21 CFR

21 CFR refers to Title 21 of the Code of Federal Regulations, which contains regulations related to food and drugs in the United States. It is enforced by the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and other federal agencies.

Here are some important sections:

Part 11 – Electronic records and electronic signatures

Part 50 – Protection of human subjects in clinical trials

Part 56 – Institutional Review Boards (IRBs)

Part 210 & 211 – Current Good Manufacturing Practice (cGMP) for drugs

Part 312 – Investigational New Drug (IND) applications

Part 820 – Quality System Regulation (QSR) for medical devices

Related Topics: