State filing guide
Waived-testing filing requirements in Tennessee for med spas and clinics.
Tennessee laboratory requirements depend on the facility model; confirm applicability with the Medical Laboratory Board before relying on a federal-only waived-testing route.
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 Tennessee's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- State licensure applicability must be confirmed with the Tennessee Medical Laboratory Board for the specific facility model.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Any Tennessee fee depends on the Board's classification of the facility; confirm that classification before quoting a state fee.
Check my test menuDated preparation steps
- 1Confirm that the complete onsite menu remains waived-only.
- 2Confirm the facility classification with the Tennessee Medical Laboratory Board before filing.
- 3Prepare CMS-116 and exact device evidence.
- 4Retain the agency response and current waived-testing rules in the file.
Frequently asked questions
What filing route does the cited Tennessee guidance describe?
Tennessee laboratory requirements depend on the facility model; confirm applicability with the Medical Laboratory Board before relying on a federal-only waived-testing route.
Which requirements are named in the cited Tennessee materials?
Federal CMS-116 Certificate of Waiver application. State licensure applicability must be confirmed with the Tennessee Medical Laboratory Board for the specific facility model.
What fee and agency-timing information was reviewed for Tennessee?
Federal Certificate of Waiver: $248 per two-year certificate. Any Tennessee fee depends on the Board's classification of the facility; confirm that classification before quoting a state fee.
Does this page confirm CLIA approval or legal compliance in Tennessee?
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.