State filing guide
Waived-testing filing requirements in Maryland for med spas and clinics.
Maryland waived testing requires the federal Certificate of Waiver plus a Maryland laboratory permit or Letter of Exception.
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 Maryland's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- Maryland laboratory Permit or Letter of Exception, selected from the facility and testing model.
- Maryland lists no state fee for this waived-testing pathway.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Maryland lists a $0 state fee and estimates two to three weeks for a complete state application; treat the estimate as non-binding.
Check my test menuDated preparation steps
- 1Classify the site for a Maryland permit versus Letter of Exception.
- 2Prepare CMS-116 and Maryland's current waived-testing materials.
- 3Submit through OHCQ and retain both federal and state evidence.
Frequently asked questions
What filing route does the cited Maryland guidance describe?
Maryland waived testing requires the federal Certificate of Waiver plus a Maryland laboratory permit or Letter of Exception.
Which requirements are named in the cited Maryland materials?
Federal CMS-116 Certificate of Waiver application. Maryland laboratory Permit or Letter of Exception, selected from the facility and testing model. Maryland lists no state fee for this waived-testing pathway.
What fee and agency-timing information was reviewed for Maryland?
Federal Certificate of Waiver: $248 per two-year certificate. Maryland lists a $0 state fee and estimates two to three weeks for a complete state application; treat the estimate as non-binding.
Does this page confirm CLIA approval or legal compliance in Maryland?
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.