Thursday, August 13, 2020 2:20:55 PM
Device Investigations Subject to IDE Regulation
FDA's investigational device exemption (IDE) regulation is found at 21 CFR part 812. Under 21 CFR 812.5, investigational devices must bear a label that states the following: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The labeling may not represent that the device is safe or effective for the purposes for which it is being investigated. 21 CFR 812.5(b). The IDE regulation also prohibits certain conduct by sponsors and investigators pertaining to the investigation and distribution of investigational devices, among other practices. See 21 CFR 812.7. https://www.fda.gov/media/87374/download
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