State filing guide
Waived-testing filing requirements in Kentucky for med spas and clinics.
Kentucky medical-laboratory licensure applies unless the specific practice model fits a statutory exemption.
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 Kentucky's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Kentucky medical-laboratory licensure unless an exemption in KRS 333.040 applies.
- Physician own-patient and qualifying pharmacy waived-testing models can be exempt; confirm facts before relying on an exemption.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Kentucky lists $155 for an initial medical-laboratory license and $80 for renewal when the state license applies.
Check my test menuDated preparation steps
- 1Classify ownership, patient relationship, facility type, and test menu under KRS 333.040.
- 2Prepare CMS-116 and the exact waived test systems.
- 3If no exemption applies, prepare the Kentucky medical-laboratory license application and fee.
Frequently asked questions
What filing route does the cited Kentucky guidance describe?
Kentucky medical-laboratory licensure applies unless the specific practice model fits a statutory exemption.
Which requirements are named in the cited Kentucky materials?
Federal CMS-116 Certificate of Waiver application. Kentucky medical-laboratory licensure unless an exemption in KRS 333.040 applies. Physician own-patient and qualifying pharmacy waived-testing models can be exempt; confirm facts before relying on an exemption.
What fee and agency-timing information was reviewed for Kentucky?
Federal Certificate of Waiver: $248 per two-year certificate. Kentucky lists $155 for an initial medical-laboratory license and $80 for renewal when the state license applies.
Does this page confirm CLIA approval or legal compliance in Kentucky?
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.