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.