Title: Title 21 of the Code of Federal Regulations
Course: BTEC-1300-301-302-303-F21 > Section: Regulations and Medical Devices

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:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.