Under 21 CFR 812, which statement regarding IDE regulation is FALSE?

The assertion that the investigator must report device use without consent within 10 days is indeed misleading and aligns with the correct choice of being false. Under 21 CFR 812, the required protocols are focused on protecting the rights of study participants and ensuring their informed consent is adequately obtained prior to any device use. However, there is no explicit requirement for the investigator to report instances of device use without obtaining consent in the stringent manner suggested within the 10-day timeframe.

In contrast, the other statements reflect accurate requirements under the regulation. For example, the investigator's obligation to report the withdrawal of Institutional Review Board (IRB) approval to the sponsor within 5 days is clearly mandated, as this is critical for maintaining regulatory compliance and participant safety. Similarly, the guidelines specify that the sponsor must notify the FDA of investigation completion within 30 days to ensure that the regulatory entity is informed about the status of clinical investigations. Lastly, the necessity for investigators to report unanticipated adverse effects within 10 days is also founded on the principle of participant safety, demanding prompt communication of unforeseen risks. These elements of if and when to report certain instances highlight the importance of maintaining transparency and oversight throughout the investigational device study process.