State filing guide
Waived-testing filing requirements in Connecticut for med spas and clinics.
Connecticut waived-only laboratories are exempt from the state clinical-laboratory license, but a separate blood-collection-facility license can still apply.
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 Connecticut's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- RCSA §19a-36-D22(b)(4) exempts laboratories that perform only CLIA-waived tests from the state clinical-laboratory license.
- Screen separately for the blood-collection-facility license under §19a-36-F2.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. No separate waived-only clinical-laboratory license fee is due under the cited exemption; any blood-collection-facility requirement is separate.
Check my test menuDated preparation steps
- 1Confirm that every onsite test system is CLIA-waived for its exact intended use.
- 2Determine whether the location separately operates as a blood-collection facility.
- 3Prepare CMS-116 and retain the exemption and device evidence in the file.
Frequently asked questions
What filing route does the cited Connecticut guidance describe?
Connecticut waived-only laboratories are exempt from the state clinical-laboratory license, but a separate blood-collection-facility license can still apply.
Which requirements are named in the cited Connecticut materials?
Federal CMS-116 Certificate of Waiver application. RCSA §19a-36-D22(b)(4) exempts laboratories that perform only CLIA-waived tests from the state clinical-laboratory license. Screen separately for the blood-collection-facility license under §19a-36-F2.
What fee and agency-timing information was reviewed for Connecticut?
Federal Certificate of Waiver: $248 per two-year certificate. No separate waived-only clinical-laboratory license fee is due under the cited exemption; any blood-collection-facility requirement is separate.
Does this page confirm CLIA approval or legal compliance in Connecticut?
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.