State filing guide
Waived-testing filing requirements in North Dakota for med spas and clinics.
North Dakota uses the federal CLIA pathway and publishes a state Laboratory Tests Performed form for the packet.
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 North Dakota's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- North Dakota SFN 53285, Laboratory Tests Performed.
- Confirm with the State Agency whether SFN 53285 is mandatory for the specific initial packet.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. No separate North Dakota waived-testing fee or universal issuance SLA is published.
Check my test menuDated preparation steps
- 1Prepare CMS-116 and SFN 53285 with exact waived test systems.
- 2Confirm the current packet requirement with North Dakota before submitting.
- 3Retain both forms and submission evidence.
Frequently asked questions
What filing route does the cited North Dakota guidance describe?
North Dakota uses the federal CLIA pathway and publishes a state Laboratory Tests Performed form for the packet.
Which requirements are named in the cited North Dakota materials?
Federal CMS-116 Certificate of Waiver application. North Dakota SFN 53285, Laboratory Tests Performed. Confirm with the State Agency whether SFN 53285 is mandatory for the specific initial packet.
What fee and agency-timing information was reviewed for North Dakota?
Federal Certificate of Waiver: $248 per two-year certificate. No separate North Dakota waived-testing fee or universal issuance SLA is published.
Does this page confirm CLIA approval or legal compliance in North Dakota?
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.