State filing guide
Waived-testing filing requirements in West Virginia for med spas and clinics.
West Virginia's Office of Laboratory Services processes the federal CMS-116 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 West Virginia's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Director-qualification documents are not required for a Certificate of Waiver application.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. West Virginia publishes no separate waived-laboratory fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Prepare CMS-116 and exact waived test systems.
- 2Submit through West Virginia OLS.
- 3Retain Pay.gov and certificate evidence.
Frequently asked questions
What filing route does the cited West Virginia guidance describe?
West Virginia's Office of Laboratory Services processes the federal CMS-116 route.
Which requirements are named in the cited West Virginia materials?
Federal CMS-116 Certificate of Waiver application. Director-qualification documents are not required for a Certificate of Waiver application.
What fee and agency-timing information was reviewed for West Virginia?
Federal Certificate of Waiver: $248 per two-year certificate. West Virginia publishes no separate waived-laboratory fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in West Virginia?
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.