title: Medical devices; investigational device exemptions--FDA. Final rule.
abstract: The Food and Drug Administration (FDA) is amending the Investigational Device Exemptions (IDE) regulation. The regulatory changes are intended to reflect amendments to the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). These amendments provide that the sponsor of an IDE may modify the device and/or clinical protocol, without approval of a new application or supplemental application, if the modifications meet certain criteria and if notice is provided to FDA within 5 days of making the change. The rule also defines the credible information to be used by sponsors to determine if the criteria are met.
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration