Medical devices; procedures for investigational device exemptions--Food and Drug Administration. Final rule.
This rule sets forth the procedures and conditions under which investigations of medical devices involving human subjects may be exempt from certain requirements of the Federal Food, Drug, and Cosmetic Act, in accordance with the Medical Device Amendments of 1976. The rule sets out the procedures to obtain an investigational device exemption (IDE); it delineates the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of medical devices; and the rule also prescribes informed consent requirements and specifies recordkeeping and reporting requirements.
D004282:Documentation / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000592:standards*; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D011367:Professional Staff Committees; D014481:United States; D014486:United States Food and Drug Administration