FDA Policy and Cardiovascular Medicine

This comprehensive review traces the FDA’s evolution from its 1862 origins through landmark legislation—the 1906 Pure Food and Drug Act, 1938 Food Drug and Cosmetic Act, 1962 Kefauver-Harris Amendments, and 1976 Medical Device Amendments—each enacted in response to public health crises and broadening the agency’s authority over drugs and devices. The authors discuss current FDA policies for approval and postmarket surveillance of new drugs, biologics, generics, and medical devices, with particular attention to their implications for cardiovascular clinical care.