mdi Consultants
16
Jan
Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens
FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that
