Zdrowie i gospodarka · 26/06/2025
FDA Classifies Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities in Hematologic Malignancies
The FDA is classifying the device into Class II, special controls, to ensure safety and effectiveness, and to reduce regulatory burdens, ultimately enhancing patients' access to innovative devices.
Source: Federal Register — Food and Drug AdministrationOpen original release →