Are in vitro diagnostic products drugs or devices?
The definition of a “device” includes all in vitro diagnostic products–devices that aid in the diagnosis of disease by using human or animal components to cause chemical reactions, fermentation, and the like. Some medical devices are intended for use in the diagnosis of conditions other than disease. An example of this would be a device used to diagnose pregnancy. • Can a committee established to review intraocular lens (IOL) studies review research involving other FDA regulated products? Yes. As long as the committee meets the membership and procedural requirements of the FDA regulations (21 CFR 56), it can review any study involving an FDA-regulated product. • What are the IRB’s general obligations towards IOL clinical investigations? An IRB is responsible for the initial and continuing review of all IOL clinical investigations conducted at its institution. Each individual IOL style is subject to independent review by the IRB. However, this does not preclude the IRB from using prior
