Which regulation is NOT part of the establishment, performance and auditing of a human-use clinical device trial?

Which regulation is NOT part of the establishment, performance and auditing of a human-use clinical device trial?

• A. 21 CFR 50 Protection of Human Subjects
• B. 21 CFR 56 IRB
• C. 21 CFR 807 Establishment Registration
• D. 21 CFR 812 IDE Exemptions

Answer: (C)

The regulation pertaining to the establishment, performance, and auditing of a human-use clinical device trial primarily focuses on protecting human subjects, overseeing Institutional Review Boards (IRBs), and the investigational device exemption processes. The regulation concerning establishment registration, which is referenced as 21 CFR 807, deals with the requirements for manufacturers and importers to register their establishment with the FDA and list their devices. While this regulation is critical for regulatory compliance, it pertains more to the manufacturing and marketing of devices rather than the specific procedures and ethical considerations of conducting clinical trials involving human subjects. On the other hand, regulations like 21 CFR 50 focus on the protection of human subjects, ensuring their safety and rights during clinical research. 21 CFR 56 outlines the requirements for IRBs, which play a fundamental role in reviewing and approving clinical trial protocols to safeguard participant welfare. 21 CFR 812 addresses the IDE (Investigational Device Exemption) regulations that govern the use of devices in clinical trials. Therefore, the focus of the question is on regulations that ensure the ethical and operational aspects of clinical trials, making establishment registration, as detailed in 21 CFR 807, the regulation that does not directly fit within that scope.

The regulation pertaining to the establishment, performance, and auditing of a human-use clinical device trial primarily focuses on protecting human subjects, overseeing Institutional Review Boards (IRBs), and the investigational device exemption processes.

The regulation concerning establishment registration, which is referenced as 21 CFR 807, deals with the requirements for manufacturers and importers to register their establishment with the FDA and list their devices. While this regulation is critical for regulatory compliance, it pertains more to the manufacturing and marketing of devices rather than the specific procedures and ethical considerations of conducting clinical trials involving human subjects.

On the other hand, regulations like 21 CFR 50 focus on the protection of human subjects, ensuring their safety and rights during clinical research. 21 CFR 56 outlines the requirements for IRBs, which play a fundamental role in reviewing and approving clinical trial protocols to safeguard participant welfare. 21 CFR 812 addresses the IDE (Investigational Device Exemption) regulations that govern the use of devices in clinical trials.

Therefore, the focus of the question is on regulations that ensure the ethical and operational aspects of clinical trials, making establishment registration, as detailed in 21 CFR 807, the regulation that does not directly fit within that scope.