US health regulators make a blood clotting test easier to get to patients

US health regulators just reclassified a specific blood test, moving it into a category with fewer regulatory hurdles. This means companies can get tests for von Willebrand disease to patients more quickly and cheaply.

The US Food and Drug Administration classifies medical devices into risk categories, with Class II being moderate risk. This reclassification means manufacturers of the von Willebrand factor assay, a test for a common inherited bleeding disorder, will face less regulatory burden. The change could lead to more available tests and better diagnosis rates for a condition that is often underdiagnosed.