1930s

The U.S. Food and Drug Administration (FDA) is given authority to regulate the premarket review of new drugs for safety by the Federal Food, Drug, and Cosmetic Act (1938).

1960s

Technology assessment arises on the basis of the recognition that modern technology may have unintended, harmful consequences.

The Kefauver-Harris Drug Amendments expand the FDA’s responsibilities to include evaluations of safety and effectiveness. Effectiveness must be proved by “substantial evidence” (1962).

1970s

Congress gives the FDA significant authority through the Medical Device Amendments to regulate the testing and marketing of medical devices to ensure their safety and efficacy (1976).

ECRI (now the ECRI Institute) publishes its first monthly publication dedicated to assessing medical technologies (1971).

Congress establishes the U.S. Office of Technology Assessment (OTA) (P.L. 92-484) to perform objective analyses of technologies, including health care services, to aid policy making (1972). (Congress eliminated funding for OTA in 1995.)

Wennberg and colleagues document wide variations in physician practices, making evident that the style of U.S. health care practice is likewise variable (1973).

Congress establishes the National Center for Health Care Technology (P.L. 95-623) in 1978 to conduct medical technology assessments related to Medicare coverage decisions. (The program was dissolved in 1981 after Congress cut its funding.)