State filing guide
Waived-testing filing requirements in Utah for med spas and clinics.
Utah administers the federal CLIA route and asks for an Ownership and Controlling Interest form with the packet.
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 Utah's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Utah Ownership and Controlling Interest form.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Utah publishes no separate state CLIA fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Prepare CMS-116 and the Ownership and Controlling Interest form.
- 2List each waived test system exactly.
- 3Submit through labimprovement@utah.gov or the current state channel.
Frequently asked questions
What filing route does the cited Utah guidance describe?
Utah administers the federal CLIA route and asks for an Ownership and Controlling Interest form with the packet.
Which requirements are named in the cited Utah materials?
Federal CMS-116 Certificate of Waiver application. Utah Ownership and Controlling Interest form.
What fee and agency-timing information was reviewed for Utah?
Federal Certificate of Waiver: $248 per two-year certificate. Utah publishes no separate state CLIA fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in Utah?
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.