Zdrowie i gospodarka · 24/11/2021

FDA Proposes Reclassification of HIV Viral Load Monitoring Tests

The Food and Drug Administration (FDA) is proposing to reclassify human immunodeficiency virus (HIV) viral load monitoring tests from a post-amendment class III device to a class II device, subject to premarket notification, in an effort to reduce regulatory burdens and provide a reasonable assurance of safety and effectiveness.