--- title: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations description: COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. image: https://blog.cola.org/hubfs/LOCS_450.jpg --- ISO 9001:2015 - [Careers](http://www.cola.org/careers/) - [A Great Place to Work](http://www.cola.org/careers/a-great-place-to-work/) - [Current Openings](http://www.cola.org/careers/current-openings/) - [Press Room](http://www.cola.org/press-room/) - Member Login - [COLAcentral](https://www.colacentral.com) - [Board of Directors](http://board.cola.org/) - visit related COLA sites - [GiveBack365](http://www.GiveBack365.org) - [Lab Testing Matters](http://www.LabTestingMatters.org) - [MyConsultantCentral](http://www.myconsultantcentral.com/) - 1-800-981-9883 ![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=306&height=111&name=ColaUpdatedLogoStackedWhiteBackground-1.png)   ![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=210&height=76&name=ColaUpdatedLogoStackedWhiteBackground-1.png)   ISO 9001:2015 - 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[Tweet](https://twitter.com/share) *COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below is a link to the most recent message on clarification from the U.S. Food and Drug Administration (FDA) about the CLIA-waived status for point-of-care SARS-CoV-2 tests under Emergency Use Authorizations.*   **FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations** The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a [CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation](https://www.cdc.gov/clia/test-complexities.html). [Read more here.](https://www.cdc.gov/csels/dls/locs/2020/fda_clarifies_clia-waived_status.html?utm_campaign=CDC%20Email&utm_source=hs_email&utm_medium=email&utm_content=2&_hsenc=p2ANqtz-9_4IxdSFUeMF_ZHvpbmdzwbEWwd5sLUn8vJuoQccJ3goq_n9dj7y_WABJgWngZeVT47vsJln0uBi1PIhr2yU60yeGpCQ&_hsmi=2)   - [FDA Updates COVID-19 Test Policy and FAQs](https://blog.cola.org/cdc-updates/fda-updates-covid-19-test-policy-and-faqs) October 10, 2022 - [CDC Issues Select Agent Gram for Monkeypox Virus](https://blog.cola.org/cdc-updates/cdc-issues-select-agent-gram-for-monkeypox-virus) October 10, 2022 - [HHS Declaration of Public Health Emergency for Monkeypox Diagnostics and New FDA Guidance](https://blog.cola.org/cdc-updates/hhs-declaration-of-public-health-emergency-for-monkeypox-diagnostics-and-new-fda-guidance) October 10, 2022 - [Variant Influenza Virus Infections](https://blog.cola.org/cdc-updates/variant-influenza-virus-infections) September 06, 2022 - [Best Practices for Suspected Monkeypox Lesion Specimen Collection](https://blog.cola.org/cdc-updates/best-practices-for-suspected-monkeypox-lesion-specimen-collection) September 05, 2022 - [FDA Updates COVID-19 Test Policy and FAQs](https://blog.cola.org/cdc-updates/fda-updates-covid-19-test-policy-and-faqs) October 10, 2022 - [CDC Issues Select Agent Gram for Monkeypox Virus](https://blog.cola.org/cdc-updates/cdc-issues-select-agent-gram-for-monkeypox-virus) October 10, 2022 - [HHS Declaration of Public Health Emergency for Monkeypox Diagnostics and New FDA Guidance](https://blog.cola.org/cdc-updates/hhs-declaration-of-public-health-emergency-for-monkeypox-diagnostics-and-new-fda-guidance) October 10, 2022 - [Variant Influenza Virus Infections](https://blog.cola.org/cdc-updates/variant-influenza-virus-infections) September 06, 2022 - [Best Practices for Suspected Monkeypox Lesion Specimen Collection](https://blog.cola.org/cdc-updates/best-practices-for-suspected-monkeypox-lesion-specimen-collection) September 05, 2022 Advertisement ### Posts by Tag - [CDC LOCS (4)](https://blog.cola.org/cdc-updates/tag/cdc-locs) Search Blog: [Careers](http://www.cola.org/careers/) | [Press Room](http://www.cola.org/press-room/) ![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=175&height=64&name=ColaUpdatedLogoStackedWhiteBackground-1.png) 9881 Broken Land Pkwy Suite 200 | Columbia, MD 21046-3016 Phone (800) 981-9883 | Fax (410) 381-8611 | Email [info@cola.org](mailto:info@cola.org) [Privacy Policy](http://www.cola.org/privacy-policy/) | [Terms Of Service](http://www.cola.org/terms-of-service/) | [Interested In Advertising?](https://education.cola.org/cola-adnetwork) - follow us: - - - - Visit: [Near Patient Testing Matters](http://www.nearpatienttestingmatters.org/) [Lab Testing Matters](http://www.labtestingmatters.org/) [My Consultant Central](http://www.myconsultantcentral.com/) Member Login: [COLAcentral](https://www.colacentral.com) [Board of Directors](http://board.cola.org/) site development by [![](https://blog.cola.org/hubfs/COLA-Jun2017/images/NL_bug.png)](http://www.nextlogik.com) © 2004 - 2017 COLA All Rights Reserved ![](https://dc.ads.linkedin.com/collect/?pid=169932&fmt=gif)