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The Food and Drug Administration's Role in Facilitating Testing for COVID-19

When the Secretary of the Department of Health and Human Services determines that there is a public health emergency and declares that circumstances exist justifying an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) can issue an EUA under section 564 of the Federal Food, Drug, and Cosmetic Act. An EUA allows for the use of certain unapproved medical products, or unapproved uses of certain approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives. FDA issued the first COVID-19 EUA for a diagnostic test to the Centers for Disease Control and Prevention and issued subsequent EUAs to other laboratories. This work will examine FDA's EUA processes and any challenges it may have faced regarding EUAs for COVID-19 diagnostic tests and serological tests for antibodies developed in response to the viral infection.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
Completed Food and Drug Administration The Food and Drug Administration's Role in Facilitating Testing for COVID-19 Office of Evaluation and Inspections 2022