How Does FDA Categorize Tests under CLIA?

Laboratory tests under CLIA fall into three categories: waived, moderate complexity and high complexity, and FDA assigns the category for test systems (42 CFR 493.5(a) and FDA CLIA categorizations page). Moderate complexity includes the subcategory of PPM procedures. The category decides which laboratory requirements apply to the site that runs the test.

Waived tests. Tests waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use, are categorized as waived (42 CFR 493.15 and FDA CLIA categorizations page).

The scorecard. For other tests, FDA reviews the package insert instructions and scores the test from 1 to 3 on each of seven criteria (42 CFR 493.17(a) and FDA CLIA categorizations page):

1. Knowledge.
2. Training and experience.
3. Reagents and materials preparation.
4. Characteristics of operational steps.
5. Calibration, quality control and proficiency testing materials.
6. Test system troubleshooting and equipment maintenance.
7. Interpretation and judgment.

A total score of 12 or less means moderate complexity, and a score above 12 means high complexity (42 CFR 493.17(a)).

Default and waiver requests. A test that does not appear on the published lists is considered high complexity until it is reviewed and categorized (42 CFR 493.17(c)(4)). A manufacturer of a moderate complexity test may ask FDA to categorize it as waived through a CLIA Waiver by Application (FDA CLIA categorizations page).

Timing. FDA categorizes a test after it clears or approves a marketing submission, or on request for legally marketed devices (FDA CLIA categorizations page).

Laboratory certificates. Each laboratory must be CLIA-exempt or hold a CLIA certificate, such as a certificate of waiver, a certificate for PPM procedures, a certificate of compliance or a certificate of accreditation (42 CFR 493.5(c)). A laboratory that performs any high complexity test must obtain a certificate for tests of high complexity (42 CFR 493.25(a)).

Related testing topics. The FAQ on whether employers can drug test on site covers on-site screening, and the FAQ on certified laboratories for drug testing covers confirmation testing.

Device rules. The FAQ on FDA drug test device classification explains how drug test systems are classified.