State filing guide
Waived-testing filing requirements in Ohio for med spas and clinics.
Ohio generally uses the federal CLIA route, with additional requirements for certain facility types and analytes.
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 Ohio's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Pharmacy testing must be screened against OAC 4729:1-3-01.
- Blood-lead testing requires separate Ohio approval, proficiency testing, and a $300 fee.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Ohio blood-lead laboratory approval is $300 when applicable; other requirements depend on facility and test classification.
Check my test menuDated preparation steps
- 1Classify the facility and exact analytes before selecting the Ohio pathway.
- 2Prepare CMS-116 for the waived-only menu.
- 3Confirm applicability and current filing mechanics with the relevant Ohio agency before adding a pharmacy or blood-lead requirement.
Frequently asked questions
What filing route does the cited Ohio guidance describe?
Ohio generally uses the federal CLIA route, with additional requirements for certain facility types and analytes.
Which requirements are named in the cited Ohio materials?
Federal CMS-116 Certificate of Waiver application. Pharmacy testing must be screened against OAC 4729:1-3-01. Blood-lead testing requires separate Ohio approval, proficiency testing, and a $300 fee.
What fee and agency-timing information was reviewed for Ohio?
Federal Certificate of Waiver: $248 per two-year certificate. Ohio blood-lead laboratory approval is $300 when applicable; other requirements depend on facility and test classification.
Does this page confirm CLIA approval or legal compliance in Ohio?
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.