State filing guide
CLIA waiver application and requirements in Texas.
Ask about my application — no payment todayTexas uses CMS-116 plus Form 3225, an additional form rather than a separate laboratory license.
Sources checked 2026-09-10 · next source check due 2026-10-10
Additional application documents
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
- HHSC requires Form 3225 as a supplement to CMS-116.
- The supplement concerns application/ownership information; its presence does not make Texas equivalent to a separate state laboratory licensing regime.
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.
Check my test menuWhat still needs confirmation for your facility
- 1Complete both forms and confirm the current county/regional submission route.
Frequently asked questions
What filing route does the cited Texas guidance describe?
Texas uses CMS-116 plus Form 3225, an additional form rather than a separate laboratory license.
Which requirements are named in the cited Texas materials?
HHSC requires Form 3225 as a supplement to CMS-116. The supplement concerns application/ownership information; its presence does not make Texas equivalent to a separate state laboratory licensing regime.
What do the sources establish about fees and timing in Texas?
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 Texas?
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 Texas CLIA route?
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From test research to your Texas 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.