FDA Seeks Feedback on Draft Guidance for In Vitro Diagnostic Devices During Public Health Emergencies
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance outlining recommendations for validating in vitro diagnostic devices (IVDs) used to detect emerging pathogens during public health emergencies. The draft guidance, titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency," addresses test data and information required for the approval of tests submitted under the Emergency Use . . .