State filing guide
CLIA waiver application and requirements in Georgia.
Ask about my application — no payment todayGeorgia repealed separate state clinical laboratory licensing on July 1, 2021; submit the federal CMS-116 through DCH.
Sources checked 2026-10-31 · next source check due 2026-11-30
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.
Get the Georgia CLIA waiver checklist by email
The federal CMS-116 steps, what Georgia's official sources say, what to confirm for your facility, and the official links, in one email you can keep. Free.
What the official sources say
- DCH states that separate state clinical-laboratory, collection-station, tissue-bank and laboratory-director licensure requirements were removed effective July 1, 2021; federal CLIA requirements remain.
- The Georgia CLIA page directs completed applications to HFRD.Diagnostic@dch.ga.gov and asks applicants to allow 30–45 business days for processing, not guaranteed certificate issuance.
- CMS currently serves CMS-116 (04/2026; CMS source rechecked 2026-11-09), OMB 0938-0581, expiration April 30, 2029; complete sections I–VI and IX–X for a waiver and obtain the owner/director signature.
- DCH lists Diagnostic Services at 404-657-5447; the September 2026 CMS directory lists 404-657-5700 and 2 Peachtree Street NW, Suite 31-447, Atlanta GA 30303-3142. No current initial-application fax was verified.
- No additional initial Georgia CLIA form or separate CLIA surcharge was identified. General facility licensure, professional scope and case-specific attachments still require review.
Fees and timing
Federal Certificate of Waiver: $248 for two years, paid through Pay.gov after the CMS emailed fee coupon; no payment with CMS-116 and no paper checks since March 1, 2026. No separate Georgia CLIA surcharge was identified; do not apply generic facility-licensure fees automatically. Government fees are separate from preparation-service fees. DCH publishes 30–45 business days for application processing; no final approval or certificate date is promised. Receive the CLIA certificate before testing.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the facility fits the initial, fixed, single-site, own-patient, waived-only office route and verify every exact test system against FDA evidence and labeling.
- 2Confirm the CMS-116 edition and signed-email attachment format: the standalone PDF remains 03/24 while a separate guide labeled November 2026 illustrates 04/2026, and the CMS listing metadata conflicts. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved.
- 3Confirm any additional case-specific attachment and the actual postal/fax destination if email cannot be used. Generic HFRD online-portal instructions differ from the CLIA-specific email instruction.
Frequently asked questions
What filing route does the cited Georgia guidance describe?
Georgia repealed separate state clinical laboratory licensing on July 1, 2021; submit the federal CMS-116 through DCH.
Which requirements are named in the cited Georgia materials?
DCH states that separate state clinical-laboratory, collection-station, tissue-bank and laboratory-director licensure requirements were removed effective July 1, 2021; federal CLIA requirements remain. The Georgia CLIA page directs completed applications to HFRD.Diagnostic@dch.ga.gov and asks applicants to allow 30–45 business days for processing, not guaranteed certificate issuance. CMS currently serves CMS-116 (04/2026; CMS source rechecked 2026-11-09), OMB 0938-0581, expiration April 30, 2029; complete sections I–VI and IX–X for a waiver and obtain the owner/director signature. DCH lists Diagnostic Services at 404-657-5447; the September 2026 CMS directory lists 404-657-5700 and 2 Peachtree Street NW, Suite 31-447, Atlanta GA 30303-3142. No current initial-application fax was verified. No additional initial Georgia CLIA form or separate CLIA surcharge was identified. General facility licensure, professional scope and case-specific attachments still require review.
What do the sources establish about fees and timing in Georgia?
Federal Certificate of Waiver: $248 for two years, paid through Pay.gov after the CMS emailed fee coupon; no payment with CMS-116 and no paper checks since March 1, 2026. No separate Georgia CLIA surcharge was identified; do not apply generic facility-licensure fees automatically. Government fees are separate from preparation-service fees. DCH publishes 30–45 business days for application processing; no final approval or certificate date is promised. Receive the CLIA certificate before testing.
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.
All 52jurisdictions →Official sources behind this guide
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