미국 의료기기 인허가 관련 조직 및 법(발행일:2004.10.18)

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□ 의료기기 관련조직 /1
 (1) FDA(Food and Drug Administration) / 1
 (2) CDRH(Center for Devices and Radiological Health) /1

□ 의료기기 관련법 및 규정 / 6
 (1) FD&C Act (Federal Food, Drug & Cosmetic Act) / 6
 (2) The Medical Device Amendments of 1976 / 6
 (3) FDAMA (The Food and Drug Administration Modernization Act of 1997) / 6
 (4) CFR (The Code of Federal Regulations) / 6
 (5) MDUFMA (Medical Device User Fee and Modernization Act of 2002) /7