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CLIA waiver state checklist
CLIA Certificate of Waiver requirements in North Carolina for med spas and clinics.
North Carolina is a CMS-116 state-agency route with mail or fax handling in older state summaries.
This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.
State overlay checklist
- Submit CMS-116 through North Carolina DHSR CLIA forms process.
- Older state summaries emphasize mail or fax routing.
- Verify if the clinic model requires additional facility or provider approvals.
Fee and timing note
Federal certificate billing after processing. Build in mailing/fax handling time unless DHSR confirms an online route.
Check my test menuPrep steps
- 1Prepare a CMS-116 test menu with exact analyte, test system, and manufacturer.
- 2Confirm current DHSR submission route before sending.
- 3Store FDA device confirmations and manufacturer instructions in the prep file.