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Zdrowie i gospodarka · 16/09/2024

FDA Classifies Device to Detect Viral Nucleic Acid in Head and Neck Cancers into Class II with Special Controls

The FDA is classifying a device that detects or measures nucleic acid from viruses associated with head and neck cancers into Class II with special controls, aiming to ensure device safety and effectiveness while enhancing patient access to innovative devices.

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