State filing guide
Waived-testing filing requirements in Montana for med spas and clinics.
Montana follows the federal CLIA route and publishes no additional state-specific laboratory regulation for waived testing.
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 Montana's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- No additional Montana clinical-laboratory license is published for waived testing.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Montana publishes no separate waived-testing fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Prepare CMS-116 and the exact waived test systems.
- 2Send through Montana's current CLIA channel.
- 3Retain submission evidence and CMS electronic notices.
Frequently asked questions
What filing route does the cited Montana guidance describe?
Montana follows the federal CLIA route and publishes no additional state-specific laboratory regulation for waived testing.
Which requirements are named in the cited Montana materials?
Federal CMS-116 Certificate of Waiver application. No additional Montana clinical-laboratory license is published for waived testing.
What fee and agency-timing information was reviewed for Montana?
Federal Certificate of Waiver: $248 per two-year certificate. Montana publishes no separate waived-testing fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in Montana?
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.