Which section outlines the criteria for Investigational Device Exemptions?

The section that outlines the criteria for Investigational Device Exemptions (IDEs) is indeed 21 CFR 812. This regulation sets forth the requirements for the conduct of clinical investigations of medical devices intended for human use. It specifies the necessary steps for sponsors to obtain exemption from the usual requirements for premarket approval in order to gather clinical data on the safety and effectiveness of investigational devices.

In 21 CFR 812, there are detailed provisions regarding the responsibilities of the sponsor, the investigator, and institutional review boards (IRBs), addressing key aspects like informed consent, reporting requirements, and the protocols that must be followed during clinical trials. This framework is essential for ensuring that investigations are conducted ethically and that participants' rights and safety are prioritized.

The other choices focus on different regulatory aspects. For instance, 21 CFR 814 Subpart H pertains specifically to humanitarian device exemptions, while 21 CFR 207 deals with registration and listing of devices. Lastly, 21 CFR 56 relates to institutional review board regulations but does not specifically address Investigational Device Exemptions. Therefore, 21 CFR 812 is the correct section relevant to IDE criteria.