State filing guide
Waived-testing filing requirements in Maine for med spas and clinics.
Maine has a separate Medical Laboratory license; limited own-patient practice exemptions depend on the exact provider and operating model.
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 Maine's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Maine Medical Laboratory license unless the facility fits an exemption or partial exemption under 22 MRS §2013-A.
- Confirm provider type, ownership, patient relationship, and specialties before relying on an exemption.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Maine lists $500 initially plus $60 per additional specialty; triennial renewal is $200 plus $60 per additional specialty when state licensure applies.
Check my test menuDated preparation steps
- 1Classify the practice under 22 MRS §2013-A.
- 2Prepare CMS-116 and the exact waived test menu.
- 3If licensure applies, prepare the Maine Medical Laboratory application and specialty schedule.
Frequently asked questions
What filing route does the cited Maine guidance describe?
Maine has a separate Medical Laboratory license; limited own-patient practice exemptions depend on the exact provider and operating model.
Which requirements are named in the cited Maine materials?
Federal CMS-116 Certificate of Waiver application. Maine Medical Laboratory license unless the facility fits an exemption or partial exemption under 22 MRS §2013-A. Confirm provider type, ownership, patient relationship, and specialties before relying on an exemption.
What fee and agency-timing information was reviewed for Maine?
Federal Certificate of Waiver: $248 per two-year certificate. Maine lists $500 initially plus $60 per additional specialty; triennial renewal is $200 plus $60 per additional specialty when state licensure applies.
Does this page confirm CLIA approval or legal compliance in Maine?
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.