How are tests approved by the FDA?

All tests seeking FDA approval go through a rigorous review process to make sure that they are safe and accurate. FDA approval is not the same as an FDA Emergency Use Authorization (EUA), which is a special status that is granted to qualifying tests during a public health emergency at the FDA’s discretion. Learn more about the approval process.

This question appears in: Children General Testing Questions

Last edited on: April 25, 2022