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

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

• A. An investigator reports withdrawal of IRB approval to the sponsor within 5 days
• B. The investigator must report device use without consent within 10 days
• C. The sponsor must notify FDA of investigation completion within 30 days
• D. An investigator must report unanticipated adverse effects within 10 days

Answer: (B)

The statement that the investigator must report device use without consent within 10 days is not accurate in the context of IDE (Investigational Device Exemption) regulations under 21 CFR 812. While it is imperative for investigators to adhere to ethical practices regarding informed consent, the specific requirement to report device use without consent within 10 days is not mandated by the regulation. In contrast, under 21 CFR 812, investigators are required to promptly report unanticipated adverse effects, typically within 10 days, ensuring that the safety of participants is prioritized. The regulations also outline that if an investigator withdraws IRB (Institutional Review Board) approval, they must communicate this to the sponsor expeditiously, and sponsors are obligated to inform the FDA of the completion of an investigation. These regulatory requirements emphasize transparency, accountability, and the ethical conduct of clinical trials involving medical devices, all of which are fundamental principles in protecting study participants.

The statement that the investigator must report device use without consent within 10 days is not accurate in the context of IDE (Investigational Device Exemption) regulations under 21 CFR 812. While it is imperative for investigators to adhere to ethical practices regarding informed consent, the specific requirement to report device use without consent within 10 days is not mandated by the regulation.

In contrast, under 21 CFR 812, investigators are required to promptly report unanticipated adverse effects, typically within 10 days, ensuring that the safety of participants is prioritized. The regulations also outline that if an investigator withdraws IRB (Institutional Review Board) approval, they must communicate this to the sponsor expeditiously, and sponsors are obligated to inform the FDA of the completion of an investigation. These regulatory requirements emphasize transparency, accountability, and the ethical conduct of clinical trials involving medical devices, all of which are fundamental principles in protecting study participants.