FDA Classifies Zika Virus Serological Reagents
May 29, 2025
May 29, 2025
WASHINGTON, May 29 (TNSFR) -- The Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, has issued a final order classifying the Zika virus serological reagents into class II with special controls.
This action, effective May 29, 2025, aims to provide a reasonable assurance of the device's safety and effectiveness, while also enhancing patient access to beneficial innovative medical devices by reducing regulatory burdens. The classifica . . .
This action, effective May 29, 2025, aims to provide a reasonable assurance of the device's safety and effectiveness, while also enhancing patient access to beneficial innovative medical devices by reducing regulatory burdens. The classifica . . .