---
title: FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests
description: COLA Inc. is engaged with the CDC’s LOCS in the DLS to transmit their public health messages to our laboratories and affiliates.
image: https://blog.cola.org/hubfs/LOCS_600.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)

 

<https://www.facebook.com/COLAorg> <https://twitter.com/COLAAccredit> <https://www.linkedin.com/company/62607> <http://www.cola.org/feed/>

![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=210&height=76&name=ColaUpdatedLogoStackedWhiteBackground-1.png)

 

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)
    - [LabUniversity](https://cola.absorbtraining.com/default.aspx#/login)
    - [Board of Directors](http://board.cola.org/)
- visit related COLA sites 
    - [COLA Resources, Inc.](http://www.criedu.org/)
    - [GiveBack365](http://www.GiveBack365.org)
    - [Lab Testing Matters](http://www.LabTestingMatters.org)
    - [LabUniversity](http://www.labuniversity.org)
    - [MyConsultantCentral](http://www.myconsultantcentral.com/)

1-800-981-9883

<https://blog.cola.org/cdc-updates/fda-issues-new-guidance-for-evaluating-impact-of-viral-mutations-on-covid-19-tests#go>

<http://www.cola.org/feed/> <https://www.linkedin.com/company/62607> <https://twitter.com/COLAAccredit> <https://www.facebook.com/COLAorg>

[![2021_newest_logo_cola-footer (1)](https://blog.cola.org/hs-fs/hubfs/2021_newest_logo_cola-footer%20(1).png?width=261&name=2021_newest_logo_cola-footer%20(1).png)](http://www.cola.org/)

- [About COLA Inc.](http://www.cola.org/cola-clia-certification-accreditation-application/) 
    - [Overview](http://www.cola.org/lab-testing-accreditation-quality/) 
          - [History Mission and Values](http://www.cola.org/cola-clia-certification-accreditation-application/)
          - [Joint Commission Affiliated Labs](http://www.cola.org/lab-testing-accreditation-quality/joint-commission-affiliated-labs/)
          - [California](http://www.cola.org/lab-testing-accreditation-quality/cola-accreditation-in-california/)
    - [Board of Directors](http://www.cola.org/cola-clia-certification-accreditation-application/board-of-directors/)
    - [Executive Team](http://www.cola.org/cola-clia-certification-accreditation-application/executives-of-cola/)
    - [News Releases](http://www.cola.org/cola-news/)
    - Additional COLA Sites 
          - [GiveBack 365](http://www.cola.org/giveback-365/)
          - [Lab Testing Matters](https://www.cola.org/lab-testing-matters/)
          - [Near Patient Testing Matters](https://www.cola.org/near-patient-testing-matters/)
          - [MyConsultantCentral](https://www.cola.org/myconsultantcentral/)
    - [Our ISO Certification](http://www.cola.org/lab-testing-accreditation-quality/iso-certification-quality-control/)
    - [Apply for COLA](http://www.cola.org/lab-testing-accreditation-quality/clia-application-clia-accreditation/)
- Quality Accreditation Services 
    - [Accreditation - Clinical Laboratory](http://www.cola.org/lab-testing-accreditation-quality/what-is-cola/)
    - [Mobile Laboratory Accreditation for EMS](https://education.cola.org/mobile-laboratory-accreditation)
    - Laboratory Experts 
          - [Surveyors](http://www.cola.org/cola-clia-certification-accreditation-application/cola-surveyors/)
    - [CDC LOCS Updates](https://blog.cola.org/updates)
    - [Insider Blog](https://blog.cola.org/blog)
    - Additional Resources 
          - [Patient Safety Program](https://www.cola.org/patient-safety/)
          - [HIPAA Information](https://www.cola.org/hipaa-information/)
          - [Lab Tests Online](https://www.cola.org/lab-tests-online/)
    - [Apply for COLA](http://www.cola.org/lab-testing-accreditation-quality/clia-application-clia-accreditation/)
- Training & Development 
    - [Individualized Quality Control Plan](https://education.cola.org/individualized-quality-control-plan-course)
    - Laboratory Enrichment Forum 
          - [Attendees](https://education.cola.org/2023-laboratory-enrichment-forum)
          - [Sponsors](https://education.cola.org/en-us/2023-sponsor)
    - [Laboratory Director Course](https://www.cola.org/laboratory-director-course/)
    - [Waived Testing Toolkit](https://education.cola.org/colas-waived-testing-toolkit)
    - [Lab Link](https://www.cola.org/lab-link/)
    - [COLA Primers/Ebooks](https://www.cola.org/education-resources/cola-primers-ebooks/)
    - [COLA's Insights](http://www.cola.org/education-resources/laboratory-education/)
    - [Webinars](http://www.cola.org/webinars/)
- [Workforce Action Alliance](https://education.cola.org/2023-workforce-action-alliance)
- FDA Services 
    - [Third Party Review](http://www.cola.org/third-party-review/)
- [Contact Us](https://education.cola.org/contact-us-page)

# FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests

- [Home](http://www.cola.org/)
- FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests

[March 03, 2021](https://blog.cola.org/cdc-updates/archive/2021/03/03) [Center for Disease Control](https://blog.cola.org/cdc-updates/author/center-for-disease-control)

<https://blog.cola.org/cdc-updates/laboratory-update-covid-19-science-update> <https://blog.cola.org/cdc-updates/confirm-your-locs-subscription-laboratories-performing-moderate-and-high-complexity-covid-19-testing-and-more>

[![](https://blog.cola.org/hubfs/LOCS_600.jpg)](https://blog.cola.org/cdc-updates/fda-issues-new-guidance-for-evaluating-impact-of-viral-mutations-on-covid-19-tests)

- [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 about new FDA guidance for evaluating the impact of viral mutations on COVID-19 tests.***

[FDA Issues New Guidance for Evaluating Impact of Viral Mutations on COVID-19 Tests](https://www.cdc.gov/csels/dls/locs/2021/labs_performing_moderate_and_high-complexity_covid-19_testing.html)

The U.S. Food and Drug Administration (FDA) recently issued new guidance for test developers. “[Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests](https://t.emailupdates.cdc.gov/r/?id=h3efad500%2C136fc1b8%2C136fd14d&ACSTrackingID=USCDC_2146-DM51058&ACSTrackingLabel=Laboratory%20Advisory%3A%20FDA%20Issues%20New%20Guidance%20for%20Evaluating%20Impact%20of%20Viral%20Mutations%20on%20COVID-19%20Tests&s=xewdZlcL0pwKOlzsEP7433hjEHxK1QqFW1FKC9mSk8U)” provides information on evaluating the potential impact of viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests.

 

- <https://blog.cola.org/cdc-updates/fda-updates-covid-19-test-policy-and-faqs>
  
  [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
- <https://blog.cola.org/cdc-updates/cdc-issues-select-agent-gram-for-monkeypox-virus>
  
  [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
- <https://blog.cola.org/cdc-updates/hhs-declaration-of-public-health-emergency-for-monkeypox-diagnostics-and-new-fda-guidance>
  
  [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
- <https://blog.cola.org/cdc-updates/variant-influenza-virus-infections>
  
  [Variant Influenza Virus Infections](https://blog.cola.org/cdc-updates/variant-influenza-virus-infections) September 06, 2022
- <https://blog.cola.org/cdc-updates/best-practices-for-suspected-monkeypox-lesion-specimen-collection>
  
  [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

- <https://blog.cola.org/cdc-updates/fda-updates-covid-19-test-policy-and-faqs>
  
  [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
- <https://blog.cola.org/cdc-updates/cdc-issues-select-agent-gram-for-monkeypox-virus>
  
  [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
- <https://blog.cola.org/cdc-updates/hhs-declaration-of-public-health-emergency-for-monkeypox-diagnostics-and-new-fda-guidance>
  
  [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
- <https://blog.cola.org/cdc-updates/variant-influenza-virus-infections>
  
  [Variant Influenza Virus Infections](https://blog.cola.org/cdc-updates/variant-influenza-virus-infections) September 06, 2022
- <https://blog.cola.org/cdc-updates/best-practices-for-suspected-monkeypox-lesion-specimen-collection>
  
  [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:
- <https://www.facebook.com/ColaInc/>
- <https://twitter.com/Cola_Inc>
- <https://www.linkedin.com/company/cola/>
- <http://www.cola.org/feed/>

 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)