FDA Lowers Risk Classifications For Bone Marrow, Diabetes Diagnostic Tests

In separate actions, the FDA recently lowered the risk classifications for a laboratory test designed to diagnose diabetes mellitus and a genetic bone marrow test for patients with leukemia or myelodysplastic syndrome. In an Aug. 25 Federal Register notice (79 Fed. Reg. 50,549), the Food and Drug Administration (FDA) issued a final order to reclassify…