State filing guide
Waived-testing filing requirements in Wisconsin for med spas and clinics.
Wisconsin ordinary waived clinical laboratories use CMS-116; separate state permits target alcohol or controlled-substance testing programs.
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 Wisconsin's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Screen separately for Wisconsin alcohol or controlled-substance testing permits.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Wisconsin publishes no separate ordinary waived-clinical-laboratory fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Classify the testing as ordinary clinical testing versus a special alcohol or drug program.
- 2Prepare CMS-116 and exact waived test systems.
- 3Submit through Wisconsin's current CLIA channel.
Frequently asked questions
What filing route does the cited Wisconsin guidance describe?
Wisconsin ordinary waived clinical laboratories use CMS-116; separate state permits target alcohol or controlled-substance testing programs.
Which requirements are named in the cited Wisconsin materials?
Federal CMS-116 Certificate of Waiver application. Screen separately for Wisconsin alcohol or controlled-substance testing permits.
What fee and agency-timing information was reviewed for Wisconsin?
Federal Certificate of Waiver: $248 per two-year certificate. Wisconsin publishes no separate ordinary waived-clinical-laboratory fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in Wisconsin?
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.