Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments.

[3] The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D.

[4] During the 1960s, the Secretary of Health, Education, and Welfare (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use.

In 1970, the study committee recommended a classification for medical devices based on comparative risk.

[5] In 1976, the Dalkon Shield intrauterine device injured at least 900,000 women in the United States,[6] which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L.