State filing guide
CLIA waiver application and requirements in North Dakota.
Ask about my application — no payment todayNorth Dakota's additional test-list and personnel requirements need a case-specific check.
Sources checked 2026-09-10 · next source check due 2026-10-10
Agency clarification needed
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
What the official sources say
- HHS lists CMS-116 and test-list SFN 53285, without clearly stating that the latter is mandatory for every initial waiver.
- Chapter 43-48 contains specific personnel exemptions and supervision conditions.
Fees and timing
Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the required packet and whether the proposed operator/test combination meets the applicable personnel exemption.
Frequently asked questions
What filing route does the cited North Dakota guidance describe?
North Dakota's additional test-list and personnel requirements need a case-specific check.
Which requirements are named in the cited North Dakota materials?
HHS lists CMS-116 and test-list SFN 53285, without clearly stating that the latter is mandatory for every initial waiver. Chapter 43-48 contains specific personnel exemptions and supervision conditions.
What do the sources establish about fees and timing in North Dakota?
Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.
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.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
Need help with your North Dakota CLIA route?
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From test research to your North Dakota application
An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.