Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Georgia
- The same 2021 law lets pharmacists order and run FDA home-use tests at a pharmacy that holds the needed CLIA certificate, including a Certificate of Waiver.
- Guides that still describe a Georgia clinical laboratory license with a physician office exemption are relying on the pre-2021 law.
Does Georgia require a state lab license on top of CLIA?
House Bill 93, signed in May 2021, rewrote Georgia's clinical laboratory chapter "to eliminate duplicative state licensure and regulation of clinical laboratories" and state lab inspections, tying Georgia's rules to federal CLIA certification instead. The older licensing rules in chapter 111-8-10 still appear in rule compilations.
- Does not reach waived-only labs
Citation: Ga. L. 2021, HB 93 (O.C.G.A. ch. 31-22)
What does Georgia charge?
No state laboratory license fee after the repeal; the lab pays the CMS certificate fee.
Do labs in other states need a Georgia license to test its specimens?
No state laboratory license was found, so a lab in another state needs nothing from this state to test its specimens beyond its own CLIA certificate.
Where does a Georgia CMS-116 go?
- Georgia Department of Community Health, Healthcare Facility Regulation Division, Diagnostic Services Unit
- Email: hfrd.diagnostic@dch.ga.gov
- Phone: (404) 657-5700
Opening a testing site in Georgia?
We prepare the CMS-116 and any Georgia filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.