State filing guide
CLIA waiver application and requirements in Hawaii.
Ask about my application — no payment todayHawaii requires an ownership disclosure with CLIA and a facility-specific state permit assessment.
Sources checked 2026-09-10 · next source check due 2026-10-10
Facility or practice conditions
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
- The CLIA application materials include CMS-116 and CMS-1513 ownership disclosure.
- The physician-office state permit exemption requires a physician laboratory director and testing exclusively for that director’s own patients. Other facilities may need a state Class I permit.
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 ownership/facility exemption and the current Class I permit requirements before omitting state paperwork.
Frequently asked questions
What filing route does the cited Hawaii guidance describe?
Hawaii requires an ownership disclosure with CLIA and a facility-specific state permit assessment.
Which requirements are named in the cited Hawaii materials?
The CLIA application materials include CMS-116 and CMS-1513 ownership disclosure. The physician-office state permit exemption requires a physician laboratory director and testing exclusively for that director’s own patients. Other facilities may need a state Class I permit.
What do the sources establish about fees and timing in Hawaii?
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 Hawaii?
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.
Official sources behind this guide
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From test research to your Hawaii application
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