EUA by FDA info & CLIA Waved 

What is an EUA?

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

 

An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidenceavailable, it is reasonable to believe that this IVD may be effective at

diagnosing recent or prior infection with SARSCoV-2 by

identifying individuals with an adaptive immune response

to the virus that causes COVID-19.

 

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used). 

 

What are the approved available alternatives?

There are no approved available alternative tests. FDA has issued EUAs for other tests that can be found at:

When FDA authorizes under EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?

A: Yes. The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes tests for use at the point of care (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

We note that the term point of care in the EUAs may include settings such as hospitals, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.

When FDA authorizes under EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?

CLIA Waived Tests (Clinical Laboratory Improvement Amendments) are those testing systems that adhere to FDA and CLIA standards of risk, error, and accuracy. In 1988, this regulation that governs the standards of testing equipment inside and outside of laboratory settings was formed to create a protocol for human specimen testing. CLIA waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria.

By ordering drug tests in bulk from SEROLOGY-TESTING you can receive a significant discount on our CLIA waived drug tests. CLIA waived testing is ideal for workplace pre-employment drug testing, random drug testing, and post-accident testing. These are hospital quality tests and used for industries such as clinicalstaffinggovernment, industrial and universities.

FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic

FDA Link to EUA Fact Sheet

Emergency Use Authorization or Medical Products

CLIA Waiver Agencies
CLIA Waiver by State