What does FDA Approved and CLIA Waived mean?

What does FDA Approved and CLIA Waived mean?

By Christopher A. Parrella,  J.D., CPC, CHC, CPCO

You may have noticed on our website that our EZ Test Cups and most of our strips are FDA approved and CLIA waived. So, what does that mean?

CLIA, which stands for Clinical Laboratory Improvement Amendments, is a federal regulation that creates quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.

The Centers for Medicare & Medicaid Services (CMS), regulates all laboratory testing (except research) performed on humans in the U.S. through CLIA. Approximately 260,000 laboratory entities are covered, according to CMS.

CLIA requires all entities that perform even one test to meet certain federal requirements, which are based on the complexity of the test and not the type of laboratory where the testing is performed. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

Waived tests include those cleared by the Food and Drug Administration for home use (such as the drug testing products that we sell) and those tests approved for waiver under the CLIA criteria. Other such at-home tests can include those for monitoring diabetes or at-home HIV detection tests, among others.

A test that is CLIA waived does not require highly trained laboratory personnel to administer it and does not require costly laboratory quality control testing. 

Although CLIA requires that waived tests must be simple and have a low risk for inaccurate results, this does not mean that waived tests are completely error-proof. Mistakes can happen anywhere in the testing process, especially when the manufacturer’s instructions are not followed or when those conducting the test are not familiar with all aspects of the test system.

If a lab is conducting only waived testing, it must have a valid Certificate of Waiver (COW) from CLIA and the lab will not be routinely inspected. However, those labs that receive a waiver may be randomly inspected as part of a compliance investigation to ensure that they are only performing waived testing.

So, what does FDA approved mean? The agency is charged with examining, testing, and approving a wide range of items for medical use. This includes everything from drugs and medical devices to tests. Getting FDA approval simply means that the agency has decided the benefits of approving the item outweigh any potential risks for its planned use.

The FDA regulates tests to detect drug use that are sold to consumers or healthcare professionals in the United States. In its review, the FDA evaluates the design and performance of the tests and sample collection systems to help ensure that they produce accurate results.

The FDA also reviews the test instructions and package inserts to ensure that those administering the test understand how to perform them easily and successfully.

The FDA does not review drug tests intended for employment and insurance testing, provided they include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (i.e. programs run by the Substance Abuse and Mental Health Services Administration, the Department of Transportation, and the U.S. military.)

Although Innovative Laboratory Solutions’ EZ Test Cup was designed for professional use where reliability is paramount, the cup is so easy to use that it is also a popular home drug test kit.

The information provided is meant to be a guide and not meant to be a substitute for professional advice. Readers are responsible for making their own assessment of the information presented here, and any use of our products based on such information. Contact us today for more information at info@eztestcup.com or call 561-218-4646.