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Zdrowie i gospodarka · 16/08/2024

FDA Classifies Device to Detect Microbial Agents Causing Acute Febrile Illness into Class II Special Controls

The FDA is classifying a device to detect and identify selected microbial agents causing acute febrile illness into Class II 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 →