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State filing guide

CLIA waiver application and requirements in New Mexico.

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New Mexico's Health Care Authority publishes the CMS-116 application route.

Sources checked 2026-09-10 · next source check due 2026-10-10

Federal application procedure

These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.

What the official sources say

  • The current HCA page directs applicants to CMS-116 and its CLIA submission address.
  • Older Department of Health links should not be used as the current filing destination.

Fees and timing

Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.

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What still needs confirmation for your facility

  1. 1Confirm the HCA contact and whether the planned operation has any special site or testing arrangement.

Frequently asked questions

What filing route does the cited New Mexico guidance describe?

New Mexico's Health Care Authority publishes the CMS-116 application route.

Which requirements are named in the cited New Mexico materials?

The current HCA page directs applicants to CMS-116 and its CLIA submission address. Older Department of Health links should not be used as the current filing destination.

What do the sources establish about fees and timing in New Mexico?

Check the current agency fee notice and fee schedule. Government fees are separate from preparation-service fees. This source summary does not promise a processing or approval date.

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.

Other jurisdictions

Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.

All 52jurisdictions →

Official sources behind this guide

Need help with your New Mexico CLIA route?

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From test research to your New Mexico application

An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.