Zdrowie i gospodarka · 11/06/2025
FDA Proposes Changes to Hematology and Pathology Devices, Including In Situ Hybridization Test Systems
The FDA is proposing to reclassify in situ hybridization test systems used with approved oncology therapeutic products into class II, subject to premarket notification, and develop new device classification regulations and special controls.
Source: Federal Register — Food and Drug AdministrationOpen original release →