State filing guide
Waived-testing filing requirements in Vermont for med spas and clinics.
Vermont processes CMS-116 and also has a statutory clinical-laboratory registration provision whose applicability must be confirmed for the facility.
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 Vermont's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Confirm applicability and current mechanics of Vermont's $25 annual clinical-laboratory registration under 18 V.S.A. §501b.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Vermont statute lists a $25 annual laboratory registration fee, but the current agency page does not resolve applicability or mechanics for every waived-only model.
Check my test menuDated preparation steps
- 1Prepare CMS-116 and exact waived test systems.
- 2Ask the Vermont Division of Licensing and Protection whether §501b registration applies to the site.
- 3Document the agency response before filing or quoting an additional state application.
Frequently asked questions
What filing route does the cited Vermont guidance describe?
Vermont processes CMS-116 and also has a statutory clinical-laboratory registration provision whose applicability must be confirmed for the facility.
Which requirements are named in the cited Vermont materials?
Federal CMS-116 Certificate of Waiver application. Confirm applicability and current mechanics of Vermont's $25 annual clinical-laboratory registration under 18 V.S.A. §501b.
What fee and agency-timing information was reviewed for Vermont?
Federal Certificate of Waiver: $248 per two-year certificate. Vermont statute lists a $25 annual laboratory registration fee, but the current agency page does not resolve applicability or mechanics for every waived-only model.
Does this page confirm CLIA approval or legal compliance in Vermont?
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.