What is USFDA Emergency Use Authorization (EUA)?

Under Emergency use authorization USFDA allows unapproved medical products (e.g. pharmaceutical, biopharmaceutical, diagostic tests, medical devices etc.) to use in market. This authorization is provided under in an emergency medical need.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Objective of Emergency Use Authorization (EUA)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Case Study>> USFDA granted emergency use authorization to Thermo Fisher’s diagnostic test to detect COVID-19