State filing guide
Waived-testing filing requirements in Hawaii for med spas and clinics.
Hawaii requires facility classification: qualifying physician-office laboratories are exempt, while other waived-only sites need a Class I state permit in addition to CLIA.
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 Hawaii's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Non-exempt waived-only facilities prepare Hawaii Form 1513 and a Class I laboratory permit.
- Confirm the physician-office exemption before omitting the state permit.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Hawaii's current Class I permit fee is $150 initially and $100 on renewal; no issuance date is promised.
Check my test menuDated preparation steps
- 1Classify the facility under current HAR 11-103.1 before selecting the state pathway.
- 2Prepare CMS-116 and the exact waived test menu.
- 3If not exempt, prepare Form 1513, the Class I permit packet, and the current state fee.
Frequently asked questions
What filing route does the cited Hawaii guidance describe?
Hawaii requires facility classification: qualifying physician-office laboratories are exempt, while other waived-only sites need a Class I state permit in addition to CLIA.
Which requirements are named in the cited Hawaii materials?
Federal CMS-116 Certificate of Waiver application. Non-exempt waived-only facilities prepare Hawaii Form 1513 and a Class I laboratory permit. Confirm the physician-office exemption before omitting the state permit.
What fee and agency-timing information was reviewed for Hawaii?
Federal Certificate of Waiver: $248 per two-year certificate. Hawaii's current Class I permit fee is $150 initially and $100 on renewal; no issuance date is promised.
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.