Hitec Medical FDA training – Introduction to FDA regulations
Code of Federal Regulations (CFR)
CFR is the integration of general and permanent rules published and published by federal government agencies and departments in the Federal Register, with universal applicability and legal effects.
There are a total of 50 CFR articles (Title), some of which have chapters (Subtitles) representing various fields of federal regulations; Each article has several parts, each of which can be further divided into chapters and sections.
21 CFR is a regulation for food, drugs, and medical devices, consisting of 9 chapters, including parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299, and 1300 to the end.
Sections 800-1299 of Chapter 8 are regulations on medical devices.
For example, 21CFR Part 820 is a review requirement for quality system regulations.
Post time: Feb-23-2024