From the Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md.
Controversies section editor: Phil B. Fontanarosa, MD, Senior Editor.
THE FOOD AND Drug Administration's (FDA's) authority for regulation
of laboratory tests (in vitro diagnostic devices or IVDs) was established
as a result of passage of the Medical Device Amendments of 1976.1
Under this law, all medical devices (including IVDs) are subject to a variety
of controls, including the requirement for manufacturers to register with
the FDA and list their products, to comply with Current Good Manufacturing
Practice, and to report serious device failures. This law provided the agency,
for the first time in the late 1970s, with an inventory of tests already in
the marketplace, tools to require that manufacturing practices be sound, and
a system to ensure that serious problems are identified and remedied. In addition,
the law put into place requirements for premarket review of medical devices
entering the market for the first time.
Gutman S, Richter K, Alpert S. Update on FDA Regulation of In Vitro Diagnostic Devices. JAMA. 1998;280(2):190-192. doi:10.1001/jama.280.2.190