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 Senate as S. 510 by Edward M. Kennedy (D–MA) on January 30, 1975; Committee consideration by Senate Committee on Commerce Senate Committee on Labor and Public Welfare House 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 H.R. 11124) 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.^[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]

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]

^ 94th U.S. Congress (December 11, 1975). "H.R.11124: Medical Device Amendments". U.S. House of Representative Bill Summary & Status. Library of Congress THOMAS. Retrieved February 9, 2013.{{cite web}}: CS1 maint: numeric names: authors list (link)
^ 94th U.S. Congress (May 28, 1976). "S.510: 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". www.congress.gov. Retrieved 2018-11-29.{{cite web}}: CS1 maint: numeric names: authors list (link)
^ Gerhard Peters; John T. Woolley. "Gerald R. Ford: "Statement on Signing the Medical Device Amendments of 1976.," May 28, 1976". The American Presidency Project. University of California - Santa Barbara. Retrieved 10 February 2013.
^ Office of the Federal Register. "Federal Food, Drug, and Cosmestic Act of June 25, 1938, Public Law 75-717, 52 Stat 1040". Enrolled Acts and Resolutions of Congress, Compiled 1789-2008. U.S. National Archives and Records Administration. Retrieved 12 February 2013.

[1] 94th U.S. Congress (December 11, 1975). "H.R.11124: Medical Device Amendments". U.S. House of Representative Bill Summary & Status. Library of Congress THOMAS. Retrieved February 9, 2013.{{cite web}}: CS1 maint: numeric names: authors list (link)

[2] 94th U.S. Congress (May 28, 1976). "S.510: 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". www.congress.gov. Retrieved 2018-11-29.{{cite web}}: CS1 maint: numeric names: authors list (link)

[3] Gerhard Peters; John T. Woolley. "Gerald R. Ford: "Statement on Signing the Medical Device Amendments of 1976.," May 28, 1976". The American Presidency Project. University of California - Santa Barbara. Retrieved 10 February 2013.

[4] Office of the Federal Register. "Federal Food, Drug, and Cosmestic Act of June 25, 1938, Public Law 75-717, 52 Stat 1040". Enrolled Acts and Resolutions of Congress, Compiled 1789-2008. U.S. National Archives and Records Administration. Retrieved 12 February 2013.

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