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CLIA waiver state checklist

CLIA Certificate of Waiver requirements in Wisconsin for med spas and clinics.

Wisconsin: the CLIA Certificate of Waiver uses the federal CMS-116 application; no separate state clinical-laboratory license is listed for waived testing.

Last reviewed 2026-07-03

This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.

State overlay checklist

  • Federal CMS-116 Certificate of Waiver application.
  • No separate state clinical-laboratory license is listed for waived testing in Wisconsin in the state workbook — confirm with the program below.

Fee and timing note

Plan for the federal CLIA certificate fee billed by CMS after processing. Fee amounts change and are not quoted here — verify current CMS and state fees and processing time on the official state page before filing.

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Prep steps

  1. 1Prepare CMS-116 with each waived analyte, test name, manufacturer, and estimated annual test volume.
  2. 2Keep a device-specific FDA waived-status printout for every test system in your internal prep file.
  3. 3Confirm current fees and processing time with the Wisconsin laboratory program (linked below) before you file.

Sources to verify

Wisconsin clinical laboratory program (official)CMS: How to apply for a CLIA certificateNCPA state CLIA-waiver requirements workbook