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CLIA waiver state checklist

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

Indiana: submit (1) CLIA Application for Certification (CMS-116); (2) Disclosure of Ownership; and (3) Methodology Test List.

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

  • Submit
  • CLIA Application for Certification (CMS-116)
  • Disclosure of Ownership
  • Methodology Test List

Fee and timing note

Plan for the federal CLIA certificate fee billed by CMS after processing, plus any Indiana state application or license fee. 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. 3Complete the Indiana state application listed above before ordering in-house testing supplies.
  4. 4Confirm current fees and processing time with the Indiana laboratory program (linked below) before you file.