CLIA waiver state checklist
CLIA Certificate of Waiver requirements in North Carolina for med spas and clinics.
North Carolina processes the federal CMS-116 through DHSR; use the current electronic submission channel.
Last regulatory review 2026-07-24
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
- Federal CMS-116 Certificate of Waiver application.
- Email the signed CMS-116 and current supporting documents to DHSR.CLIA@dhhs.nc.gov.
Fee and timing note
Federal Certificate of Waiver: $248 per two-year certificate. North Carolina DHSR publishes no universal issuance SLA.
Check my test menuPrep steps
- 1Prepare CMS-116 with exact waived analytes, devices, and annual volumes.
- 2Email the signed packet to DHSR.CLIA@dhhs.nc.gov.
- 3Retain the sent message and all agency responses as submission evidence.
Frequently asked questions
Does North Carolina require more than the federal CLIA Certificate of Waiver?
North Carolina processes the federal CMS-116 through DHSR; use the current electronic submission channel.
What extra steps does North Carolina add for waived point-of-care testing?
Federal CMS-116 Certificate of Waiver application. Email the signed CMS-116 and current supporting documents to DHSR.CLIA@dhhs.nc.gov.
How much does a CLIA waiver cost in North Carolina and how long does it take?
Federal Certificate of Waiver: $248 per two-year certificate. North Carolina DHSR publishes no universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in North Carolina?
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.