Medical Devices and Radiation Emitting Products Regulation: Food and Drug Law Book 4 of 12

The reliance on medical devices is far from a new phenomenon. The earliest attempt in the United States to regulate fraudulent medical devices was the 1872 Postal Fraud Statute, enforced by the United States Post Office and the Postmaster General. The 1906 Pure Food and Drugs Act did not provide for regulatory authority for devices. Subsequently, the 1938 Food, Drug and Cosmetic Act (FDCA) provided definitions yet was lacking in regulatory oversight such as postmarket surveillance. By 1947,...