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: