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State filing guide

CLIA waiver application and requirements in Georgia.

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Georgia repealed separate state clinical laboratory licensing on July 1, 2021.

Sources checked 2026-09-10 · next source check due 2026-10-10

Federal application procedure

These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.

What the official sources say

  • The DCH repeal notice states that the clinical laboratory licensing requirement was removed.
  • Federal CLIA certification remains necessary for covered testing; the repeal is not a promise of approval or short processing time.

Fees and timing

Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.

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What still needs confirmation for your facility

  1. 1Use the current CLIA application destination and confirm that the planned activity is within the waived-only scope.

Frequently asked questions

What filing route does the cited Georgia guidance describe?

Georgia repealed separate state clinical laboratory licensing on July 1, 2021.

Which requirements are named in the cited Georgia materials?

The DCH repeal notice states that the clinical laboratory licensing requirement was removed. Federal CLIA certification remains necessary for covered testing; the repeal is not a promise of approval or short processing time.

What do the sources establish about fees and timing in Georgia?

Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.

Does this page confirm CLIA approval or legal compliance in Georgia?

No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.

Other jurisdictions

Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.

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Official sources behind this guide

Need help with your Georgia CLIA route?

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From test research to your Georgia application

An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.