State filing guide
Waived-testing filing requirements in Oregon for med spas and clinics.
Oregon does not require a separate clinical-laboratory license in addition to CLIA for an ordinary waived-only laboratory.
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 Oregon's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Screen separately for health-screening-event permits or nonmedical substance-testing rules.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Oregon publishes no separate ordinary waived-laboratory fee or universal issuance SLA.
Check my test menuDated preparation steps
- 1Confirm the activity is ordinary clinical waived testing rather than a special screening or nonmedical program.
- 2Prepare CMS-116 and device evidence.
- 3Submit through Oregon's CLIA channel.
Frequently asked questions
What filing route does the cited Oregon guidance describe?
Oregon does not require a separate clinical-laboratory license in addition to CLIA for an ordinary waived-only laboratory.
Which requirements are named in the cited Oregon materials?
Federal CMS-116 Certificate of Waiver application. Screen separately for health-screening-event permits or nonmedical substance-testing rules.
What fee and agency-timing information was reviewed for Oregon?
Federal Certificate of Waiver: $248 per two-year certificate. Oregon publishes no separate ordinary waived-laboratory fee or universal issuance SLA.
Does this page confirm CLIA approval or legal compliance in Oregon?
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.