State filing guide
Waived-testing filing requirements in Virginia for med spas and clinics.
Virginia administers the federal CLIA route and does not separately license clinical laboratories or laboratory personnel.
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 Virginia's cited terminology
- Federal CMS-116 Certificate of Waiver application with original signature.
- Virginia's separate Lyme-test result notice rule remains applicable when that testing is performed.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Virginia states that it processes applications within 30 days of receipt; this is not a promised certificate date.
Check my test menuDated preparation steps
- 1Prepare original-signature CMS-116 and exact waived test systems.
- 2Screen the menu for Virginia-specific notice duties.
- 3Mail the packet through Virginia DACS and retain delivery evidence.
Frequently asked questions
What filing route does the cited Virginia guidance describe?
Virginia administers the federal CLIA route and does not separately license clinical laboratories or laboratory personnel.
Which requirements are named in the cited Virginia materials?
Federal CMS-116 Certificate of Waiver application with original signature. Virginia's separate Lyme-test result notice rule remains applicable when that testing is performed.
What fee and agency-timing information was reviewed for Virginia?
Federal Certificate of Waiver: $248 per two-year certificate. Virginia states that it processes applications within 30 days of receipt; this is not a promised certificate date.
Does this page confirm CLIA approval or legal compliance in 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.