State filing guide
Waived-testing filing requirements in South Dakota for med spas and clinics.
South Dakota follows the federal CLIA pathway; there is no general separate state clinical-laboratory application or license.
Official sources reviewed 2026-07-24 · review due 2026-08-23
This dated guide is educational. It does not confirm approval, legal compliance, applicability to a specific facility, or waived status for any device.
Requirements using South Dakota's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Assess separately whether the underlying healthcare facility type needs a South Dakota license.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. South Dakota publishes no separate general waived-laboratory fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Classify any license required by the underlying facility type.
- 2Prepare CMS-116 and exact waived test systems.
- 3Email the federal packet to SDCLIA@state.sd.us.
Frequently asked questions
What filing route does the cited South Dakota guidance describe?
South Dakota follows the federal CLIA pathway; there is no general separate state clinical-laboratory application or license.
Which requirements are named in the cited South Dakota materials?
Federal CMS-116 Certificate of Waiver application. Assess separately whether the underlying healthcare facility type needs a South Dakota license.
What fee and agency-timing information was reviewed for South Dakota?
Federal Certificate of Waiver: $248 per two-year certificate. South Dakota publishes no separate general waived-laboratory fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in South Dakota?
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.