Zdrowie i gospodarka · 21/02/2020

FDA Proposes Reclassification of HIV Diagnostic Tests to Class II Devices

The US Food and Drug Administration (FDA) is proposing to reclassify certain HIV serological and nucleic acid diagnostic tests from Class III to Class II devices, subject to premarket notification, to reduce regulatory burdens and provide a reasonable assurance of safety and effectiveness. This move aims to streamline the approval process for these devices.