The Medical Device Regulation ActorMedical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments.[1][2] The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford.[3]
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Long title | An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes. |
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Enacted by | the 94th United States Congress |
Effective | May 28, 1976 |
Citations | |
Public law | 94-295 |
Statutes at Large | 90 Stat. 539 |
Codification | |
Acts amended | Federal Food, Drug and Cosmetic Act |
Titles amended | 21 U.S.C.: Food and Drugs |
U.S.C. sections created | 21 U.S.C. ch. 9, subch. V §§ 360c:Sec. 513, 360d:Sec. 514, 360e:Sec. 515, 360f:Sec. 516, 360g:Sec. 517, 360h:Sec. 518, 360i:Sec. 519, 360j:Sec. 520, 360k:Sec. 521 |
U.S.C. sections amended |
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Legislative history | |
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Major amendments | |
Safe Medical Device Amendments of 1990 |
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. Roosevelt.[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. 94-295.[7]
Classification of Medical Devices
There are three classifications for medical devices:
Classification Panels for Medical Devices
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