Investigational Drugs & Devices

The Section is Under Development

Drugs, devices and biologics are referred to as "test articles" in the federal regulations and all are regulated by the US Food and Drug Administration (US FDA). Any clinical investigations of a test article requires that the IRB apply the FDA's regulations for Protection of Human Subjects at 21 CFR 50 and for Institutional Review Boards at 21 CFR 56. The use of a drug outside its labeled indication, regardless of whether or not the drug is the object of the investigation requires the IRB to apply 21 CFR 50 and 56. However, devices, approved or un-approved, are only investigational devices when the study is investigating their safety and/or efficacy. This means that studies of unapproved devices might not require the IRB to apply the FDA's IRB and human subjects protection regulations.


It is important to make the distinction between the study funder and the study sponsor; the terms are not synonymous. Although widely used in connection with the funding of research projects, the term sponsor conveys a different meaning in the context of FDA-regulated research. The sponsor is the individual or entity that is responsible for the oversight of the clinical trial and for all communications with the FDA.



What is a drug?


These pages provide an overview of the use of FDA regulated devices in research. The FDA's regulations for devices are less frequently encountered by both investigators and IRBs and differ substantially from the regulations for the study of drugs or biologics. Devices fall into different classes, based on their inherent risk and only some investigational devices require an IDE (investigational device exemption).