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| leghisturl= http://thomas.loc.gov/cgi-bin/bdquery/z?d094:HR11124: | introducedin= House of Representatives | introducedbill= | introducedby= Paul Rogers (D–FL) | introduceddate= December 11, 1975 | committees= Committee on Interstate and Foreign Commerce | passedbody1= House | passeddate1= March 9, 1976 | passedvote1= (362-32 ) | passedbody2= Senate | passeddate2= April 17, 1975 | passedvote2= (88-5 ), in lieu of | conferencedate= May 13, 1976 | agreedbody3= House | agreeddate3= May 13, 1976 | agreedvote3= cleared | agreedbody4= Senate | agreeddate4= May 13, 1976 | agreedvote4= cleared | signedpresident = Gerald R. Ford | signeddate = May 28, 1976 | amendments = Safe Medical Device Amendments of 1990 | SCOTUS cases = }} 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. ==History== 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. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Medical Device Regulation Act」の詳細全文を読む スポンサード リンク
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