Medical Device Regulation Act

Medical Device Amendments of 1976

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.
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	21 U.S.C. ch. 9, subch. II § 321 21 U.S.C. ch. 9, subch. III §§ 331, 334 21 U.S.C. ch. 9, subch. V §§ 351, 352, 358, 360 21 U.S.C. ch. 9, subch. VII §§ 374, 379e 21 U.S.C. ch. 9, subch. VIII § 381
Legislative history
Introduced in the House of Representatives as H.R. 11124 by Paul Rogers (D–FL) on December 11, 1975 Committee consideration by Committee on Interstate and Foreign Commerce Passed the House on March 9, 1976 (362-32) Passed the Senate on April 17, 1975 (88-5, in lieu of S. 510) with amendment House agreed to Senate amendment on May 13, 1976 (cleared) with further amendment Senate agreed to House amendment on May 13, 1976 (cleared) Signed into law by President Gerald R. Ford on May 28, 1976
Major amendments
Safe Medical Device Amendments of 1990

The Medical Device Regulation Act or Medical 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. The Title 21 amendments were signed into law on May 28, 1976 by the 38th President of the United States Gerald R. Ford.

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.

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. In 1976, the Dalkon Shield intrauterine device injured at least 900,000 women in the United States, which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L. 94-295.

Classification of Medical Devices
There are three classifications for medical devices:

Classification Panels for Medical Devices

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