Regulatory Aspects and Strategy in Medical Device and Bio Materials Safety Evaluation / 7

The U.S. federal regulations that govern the testing, manufacture, and sale of medical devices are covered in Chapter 1, Title 21 of the Code of Federal Regulations (21 CFR). These comprise nine 6 × 8 inch volumes which stack 8 inches high. This title also covers foods, veterinary products, medical devices, and cosmetics. As these topics will be discussed elsewhere in this book, here we will briefly review those parts of 21 CFR that are applicable to medical devices (Gad, 2001; Heller, 1999).