The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. Each title (or volume) of the CFR is revised once each calendar year.
Chapter 1 of Title 21 is reserved for rules of the Food and Drug Administration.
This table shows the broad jurisdiction of the FDA and the information available in chapter 1 of Title 21.
100 series |
Current good manufacturing practices for Food and Dietary supplements |
---|---|
200 & 300 series |
Current good manufacturing practices for Pharmaceuticals |
500 series |
Animal feeds & medications |
600 series |
Current good manufacturing practices for Biological products |
700 series |
Cosmetics (limited regulations) |
800 series |
Current good manufacturing practices for medical devices |
900 series |
Mammography quality requirements |
1000 series |
Radiation emitting device |
1100 series |
Tobacco products |
1200 series |
Non-FD&C Act rulings |
The portion of of Title 21 that most concerns your work in this course and in the medical device industry is 21 (Title 21) CFR (code of federal regulations) 820 (section number).
The 800 series are dedicated to current good manufacturing practices for the manufacture of medical devices. Part 820 specifically discusses Quality system regulations. A quality system is the framework a company employs to ensure they are complying with medical device regulations.
Learning Objectives: