State filing guide
Waived-testing filing requirements in Rhode Island for med spas and clinics.
Rhode Island requires a state clinical-laboratory license in addition to federal CLIA certification.
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 Rhode Island's cited terminology
- Rhode Island clinical-laboratory license for the applicable specialty.
- Federal CMS-116 Certificate of Waiver application.
- A separate screening-program permit may apply to the operating model.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Rhode Island lists $650 biennially per approved specialty and $70 for a screening-program permit.
Check my test menuDated preparation steps
- 1Classify the laboratory specialty and whether the service is a screening program.
- 2Prepare the Rhode Island license packet and CMS-116.
- 3Confirm the selected fee immediately before filing.
Frequently asked questions
What filing route does the cited Rhode Island guidance describe?
Rhode Island requires a state clinical-laboratory license in addition to federal CLIA certification.
Which requirements are named in the cited Rhode Island materials?
Rhode Island clinical-laboratory license for the applicable specialty. Federal CMS-116 Certificate of Waiver application. A separate screening-program permit may apply to the operating model.
What fee and agency-timing information was reviewed for Rhode Island?
Federal Certificate of Waiver: $248 per two-year certificate. Rhode Island lists $650 biennially per approved specialty and $70 for a screening-program permit.
Does this page confirm CLIA approval or legal compliance in Rhode Island?
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.