Zdrowie i gospodarka · 16.10.2020
Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry." The guidance provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2019.