Zdrowie i gospodarka · 17/08/2026
FDA Reclassifies Hematology and Pathology Devices for Oncology Therapeutic Products
The US Food and Drug Administration (FDA) is reclassifying certain in situ hybridization test systems used with approved cancer treatments into Class II devices, requiring premarket notification, and establishing new safety and effectiveness guidelines.
Source: Federal Register — Health and Human ServicesOpen original release →