Zdrowie i gospodarka · 21/08/2025
FDA Classifies Device Detecting Nucleic Acid Sequences for Vaginitis and Bacterial Vaginosis
The FDA is classifying a device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis 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 →