CLIA Waiver

What is CLIA categorization?

The Clinical Laboratory Improvement Amendments apply to facilities that examine materials derived from the human body to provide information for diagnosis, prevention or treatment of disease or impairment, or health assessment, subject to defined exceptions. Tests within this framework are categorized as waived, moderate or high complexity. The FDA categorizes tests after clearance or approval using factors such as operator knowledge, reagent handling, calibration, troubleshooting and interpretation, while CMS administers laboratory certification.

What does "waived" change?

A waived test may be performed by a facility holding a CLIA Certificate of Waiver, including many physician offices, pharmacies and clinics. That expands the types of sites that can perform the test compared with moderate- or high-complexity testing, but it does not remove all obligations. The site must hold the correct certificate, follow the manufacturer's instructions and comply with applicable federal and state requirements. Waived status is therefore a laboratory-use classification, not a claim that erroneous results are impossible.

How does a manufacturer obtain a waiver?

Some test systems are waived by regulation. For another eligible test, a manufacturer may submit a CLIA Waiver by Application showing that it is simple and has an insignificant risk of an erroneous result, commonly using flex studies and studies with intended untrained operators. FDA also offers a Dual 510(k) and CLIA Waiver by Application route that coordinates premarket clearance and waiver review.

How does CLIA relate to FDA device regulation?

They are complementary regimes. FDA regulates an IVD as a product through the applicable device pathway and categorizes the test; CMS regulates laboratories under CLIA. An IVD manufacturer entering the United States may need to plan authorization, categorization and waiver evidence together. Laboratory developed tests also operate within CLIA-certified laboratories, but their FDA status is a separate legal and policy question.