HIV Blood Tests to Reach More Patients With FDA Reclassification

Makers of HIV blood tests will soon no longer need to seek premarket approval from the FDA under a final agency order that aims to expand patient access to the devices.

The Food and Drug Administration said in a Federal Register notice Friday that manufacturers of HIV viral load monitoring tests, which can detect how much of the virus is in a person’s blood, can now go through the premarket notification, or 510(k), pathway, instead of the more stringent premarket approval application process. It would apply to manufacturers of tests similar to Abbott’s RealTime HIV-1 Viral Load assay.

The order, ...