Question:

How does CMS determine whether a test is moderate or high complexity, or if it is waived?

Answer:

For moderate and high-complexity tests, the Food & Drug Administration (FDA) evaluates each new commercial test system during the premarket approval process by scoring seven criteria as described in the CLIA regulations. The final score is used to determine whether the test system is classified as moderate or high complexity.

For waived tests, the FDA may grant a waiver to:

  • Any test listed in the regulation
  • Any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met
  • Test systems cleared by the FDA for home use.
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