State filing guide
Waived-testing filing requirements in New Mexico for med spas and clinics.
New Mexico's State Agency processes CMS-116; current official materials do not resolve whether every facility and test model avoids an additional state laboratory requirement.
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 New Mexico's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- State licensure applicability is unresolved for the specific facility and test model; confirm it with the New Mexico State Agency before filing.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. New Mexico publishes no universal issuance SLA; confirm any additional state fee or filing requirement for the exact facility model.
Check my test menuDated preparation steps
- 1Prepare CMS-116 with exact waived analytes, devices, and annual volumes.
- 2Ask the New Mexico State Agency whether the facility type and test menu trigger any separate state requirement.
- 3Document the agency response and current submission channel before filing.
Frequently asked questions
What filing route does the cited New Mexico guidance describe?
New Mexico's State Agency processes CMS-116; current official materials do not resolve whether every facility and test model avoids an additional state laboratory requirement.
Which requirements are named in the cited New Mexico materials?
Federal CMS-116 Certificate of Waiver application. State licensure applicability is unresolved for the specific facility and test model; confirm it with the New Mexico State Agency before filing.
What fee and agency-timing information was reviewed for New Mexico?
Federal Certificate of Waiver: $248 per two-year certificate. New Mexico publishes no universal issuance SLA; confirm any additional state fee or filing requirement for the exact facility model.
Does this page confirm CLIA approval or legal compliance in New Mexico?
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.