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FDA Finalizes CLIA Waiver Guidance Docs

 
• By Elizabeth Orr

The US FDA has issued final versions of two guidance documents related to diagnostic tests that can be performed outside clinical labs. One updates the process for applying for a waiver of the Clinical Laboratory Improvement Amendments, while the other discusses trial designs for use in dual 510(k)/CLIA waiver applications.

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Two recently finalized guidance documents update the US Food and Drug Administration’s requirements around clearances and waivers for diagnostic tests that can be performed outside laboratory settings. 

The Clinical Laboratory Improvement Amendments, or CLIA, require that tests meeting a certain standard of complexity be performed in a certified clinical laboratory. For a test to be performed outside...

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