State filing guide
Waived-testing filing requirements in Nebraska for med spas and clinics.
Nebraska requires federal CLIA certification but does not license CLIA laboratories or laboratory personnel separately.
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 Nebraska's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Nebraska Ownership Information Form and List of Tests Performed with the initial packet.
- No separate Nebraska laboratory or personnel license.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Nebraska publishes no separate state laboratory fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Prepare CMS-116, the Ownership Information Form, and List of Tests Performed.
- 2List each waived test system exactly.
- 3Submit through Nebraska DHHS and retain the complete packet.
Frequently asked questions
What filing route does the cited Nebraska guidance describe?
Nebraska requires federal CLIA certification but does not license CLIA laboratories or laboratory personnel separately.
Which requirements are named in the cited Nebraska materials?
Federal CMS-116 Certificate of Waiver application. Nebraska Ownership Information Form and List of Tests Performed with the initial packet. No separate Nebraska laboratory or personnel license.
What fee and agency-timing information was reviewed for Nebraska?
Federal Certificate of Waiver: $248 per two-year certificate. Nebraska publishes no separate state laboratory fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in Nebraska?
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.