Zdrowie i gospodarka · 21/08/2025
FDA Classifies Mutation Detection Test for Myeloproliferative Neoplasms into Class II
The FDA is classifying the mutation detection test for myeloproliferative neoplasms into class II, citing a reasonable assurance of safety and effectiveness, and aims to reduce regulatory burdens, thereby enhancing patients' access to innovative devices.
Source: Federal Register — Food and Drug AdministrationOpen original release →