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State filing guide

Waived-testing filing requirements in South Carolina for med spas and clinics.

South Carolina uses CMS-116 plus the current state CLIA packet supplied by DPH.

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 Carolina's cited terminology

  • Federal CMS-116 Certificate of Waiver application.
  • South Carolina CLIA packet requested from SC_CLIA@dph.sc.gov.

Reviewed fee and agency-timing note

Federal Certificate of Waiver: $248 per two-year certificate. South Carolina estimates certificate availability within 30 days after processing and payment; do not promise that date.

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Dated preparation steps

  1. 1Request the current South Carolina packet.
  2. 2Prepare CMS-116 and every document listed in that packet.
  3. 3Submit together and retain payment and certificate evidence.

Frequently asked questions

What filing route does the cited South Carolina guidance describe?

South Carolina uses CMS-116 plus the current state CLIA packet supplied by DPH.

Which requirements are named in the cited South Carolina materials?

Federal CMS-116 Certificate of Waiver application. South Carolina CLIA packet requested from SC_CLIA@dph.sc.gov.

What fee and agency-timing information was reviewed for South Carolina?

Federal Certificate of Waiver: $248 per two-year certificate. South Carolina estimates certificate availability within 30 days after processing and payment; do not promise that date.

Does this page confirm CLIA approval or legal compliance in South 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.