Zdrowie i gospodarka · 14.06.2019
Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry." The draft guidance document provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations.