chapter  2
14 Pages


Regulation of medical devices is intended to protect consumer's health and safety by attempting to ensure that marketed products are effective and safe. Prior to 1976, the FDA had limited authority over medical devices under the Food, Drug, and Cosmetic Act of 1938. Beginning in 1968, Congress established a radiation control program to authorize the establishment of standards for electronic products, including medical and dental radiology equipment. From the early 1960s to 1975, concern over devices increased and six United States Presidential messages were given to encourage medical device legislation.