Which regulation does NOT pertain to the establishment and performance of a human-use clinical device trial?

The regulation that does not pertain to the establishment and performance of a human-use clinical device trial is 21 CFR 807, which focuses on Establishment Registration. This regulation requires medical device manufacturers to register their establishments and list their devices with the FDA but does not directly address the protocols or requirements necessary for conducting clinical trials involving human subjects.

In contrast, 21 CFR 50 outlines the protection of human subjects in research, ensuring that individuals are ethically treated and informed about risks in clinical studies. Similarly, 21 CFR 56 sets regulations for Institutional Review Boards (IRBs) that review and oversee clinical trials to protect the rights and welfare of participants. Additionally, 21 CFR 812 provides guidelines regarding Investigational Device Exemptions (IDEs), which are crucial for legally conducting clinical trials with investigational devices.

Therefore, while the other regulations are directly involved in ensuring the ethical and procedural integrity of human clinical trials, 21 CFR 807 is focused on administrative aspects of device registration and is not concerned with the conduct of trials themselves.