Clinical Chemistry, Vol 42, 786-789, Copyright © 1996 by American Association for Clinical Chemistry

Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective

S Gutman
Division of Clinical Laboratory Devices, Food and Drug Administration, Rockville, MD 20850, USA.

The Division of Clinical Laboratory Devices is responsible for the premarket review of in vitro diagnostic devices (laboratory tests). We currently process >1000 diverse applications per year. New versions of old devices are handled as premarket notifications, so-called 510(k) submissions. The review objective is to establish that the new product is "substantially equivalent" to its predicate. Fundamentally new devices are handled as premarket applications. The review objective is to establish de novo that the product is safe and effective. A central regulatory issue over the past several years has been the development of a standardized model for scientific review. The Food and Drug Administration contributes to the quality of in vitro diagnostic devices by providing oversight and objective review, by setting thresholds for product safety and effectiveness, and by ensuring that organized data and appropriate labeling is present in support of a device's intended use.