<p>CLIA is a user-fee funded federal organization that establishes quality standards for all <a href="/resources/glossary/define-laboratory-urine-drug-test">laboratory testing</a> to ensure the accuracy, reliability and timeliness of patient test results.</p>
<p>The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. The section of the statute specifying the criteria for categorizing a test as waived was excerpted without elaboration in the regulations at 42 <abbr title="Code of Federal Regulations">CFR</abbr> 493.15(b) and 493.15(c) contained a list of these waived tests as described in Regulations (42 CFR part 493).</p>
<p><strong>Resources</strong>:</p>
<ul>
<li><a class="OffSiteLink" href="https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhtransparency/ucm578178.htm" target="_blank" rel="noopener">Information on CLIA Waivers</a></li>
<li><a href="/resources/glossary/define-clia-waived-drug-tests">CLIA Waived Drug Testing Kits</a></li>
</ul>

