Business · 07/05/2008Updated: 10/17/2026 · 1 min read

FDA Announces Availability of Guidance on CLIA Categorization for In Vitro Diagnostic Tests

The Food and Drug Administration (FDA) has released a guidance document outlining its procedures for categorizing commercially available in vitro diagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), aiming to expedite the process for manufacturers.