Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?

The correct choice indicates a misunderstanding of the reporting requirements outlined in 21 CFR 812 concerning the use of investigational devices. Statement B incorrectly states the timeline for reporting device use without obtaining informed consent. Under the IDE regulation, when an investigator uses a device without informed consent, the investigator is indeed required to report this situation, but they must do so to both the sponsor and the reviewing IRB. However, the timeframe specified in the statement is incorrect; that report must be made within 5 working days, not 10.

To clarify the other statements: the first statement accurately reflects the requirement for investigators to report to the sponsor within 5 working days if the Institutional Review Board (IRB) withdraws its approval, which ensures that the sponsor is quickly informed of any significant changes in a study's ethical oversight. The third statement correctly identifies the sponsor's responsibility to notify the FDA within 30 working days after the completion or termination of an investigation for a significant risk device, which allows for proper FDA oversight and monitoring of investigational devices. Lastly, the statement regarding the reporting of any unanticipated adverse device effects aligns with the requirement for investigators to report such incidents within 10 working days after they become aware of the effects, ensuring that both the