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CLIA waiver state checklist

CLIA Certificate of Waiver requirements in Georgia for med spas and clinics.

Georgia uses CMS-116; confirm whether the facility type and test menu also require a Georgia clinical-laboratory application.

State confirmation required before filing

This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.

State-specific requirements checklist

  • Clinical laboratory licensure application packet may be required before or alongside CLIA processing.
  • Some narrow pharmacy waived-test scenarios may be exempt from state licensure, but not from CMS-116 submission.
  • Confirm applicability with Georgia Department of Community Health for med-spa or clinic models.

Fee and timing note

Expect state-agency review when a licensure packet is needed. Verify current DCH processing and fees.

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Prep steps

  1. 1Prepare CMS-116 plus the Georgia clinical laboratory licensure packet if applicable.
  2. 2Do not assume pharmacy-only notes apply to a med-spa, GLP-1 clinic, or DPC clinic.
  3. 3Document the state-agency contact and response in the prep file.

Frequently asked questions

Does Georgia require more than the federal CLIA Certificate of Waiver?

Georgia uses CMS-116; confirm whether the facility type and test menu also require a Georgia clinical-laboratory application.

What extra steps does Georgia add for waived point-of-care testing?

Clinical laboratory licensure application packet may be required before or alongside CLIA processing. Some narrow pharmacy waived-test scenarios may be exempt from state licensure, but not from CMS-116 submission. Confirm applicability with Georgia Department of Community Health for med-spa or clinic models.

How much does a CLIA waiver cost in Georgia and how long does it take?

Expect state-agency review when a licensure packet is needed. Verify current DCH processing and fees.

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.