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Zdrowie i gospodarka · 09/05/2025

FDA Classifies Device to Detect Sexually Transmitted Infections, Citing Enhanced Patient Access and Safety

The US Food and Drug Administration (FDA) is classifying a device to detect nucleic acids from non-viral microorganisms causing STIs and associated resistance markers into Class II, special controls, aiming to improve patient access and safety.

Source: Federal Register — Food and Drug AdministrationOpen original release →