What is a Waived Test?

Waived tests are test systems that have been determined by the FDA to be so simple that there is little risk of error.  Examples include glucose testing, certain types of urine drug testing, pregnancy tests, and fecal occult blood tests.  The FDA lists all waived tests on its website at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

If what you are testing for does not appear on the FDA list, then it is not a waived test, and you need more than just a CLIA Certificate of Waiver to do it.  You would need a moderate or high complexity certificate (depending on the circumstances).

We know that all of this can be overwhelming.  That's why we will help you ensure that all tests you perform are waived tests.