Zdrowie i gospodarka · 13/06/2025
FDA Classifies Device to Detect Fungal Nucleic Acids in Respiratory Specimens into Class II Special Controls
The FDA is classifying a device that detects and identifies fungal nucleic acids directly in respiratory specimens into Class II special controls, aiming to enhance patient access to innovative devices while ensuring safety and effectiveness.
Source: Federal Register — Food and Drug AdministrationOpen original release →