CLIA waiver state checklist
CLIA Certificate of Waiver requirements in Texas for med spas and clinics.
Texas routes CLIA applications through HHSC and requires its Form 3225 supplement.
State confirmation required before filing
This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.
State-specific requirements checklist
- Form 3225, Application for Certification - Supplement to CMS 116.
- Listing of tests performed, ownership disclosure, and qualification appraisal details are common checklist items.
- Submit through the appropriate HHSC CLIA State Agency regional office.
Fee and timing note
Federal certificate billing follows processing. Review of the additional Texas form can add operational lead time.
Check my test menuPrep steps
- 1Prepare CMS-116 and Form 3225 together.
- 2Attach the planned test list by analyte, test system, and manufacturer.
- 3Confirm regional office submission instructions before mailing or uploading.
Frequently asked questions
Does Texas require more than the federal CLIA Certificate of Waiver?
Texas routes CLIA applications through HHSC and requires its Form 3225 supplement.
What extra steps does Texas add for waived point-of-care testing?
Form 3225, Application for Certification - Supplement to CMS 116. Listing of tests performed, ownership disclosure, and qualification appraisal details are common checklist items. Submit through the appropriate HHSC CLIA State Agency regional office.
How much does a CLIA waiver cost in Texas and how long does it take?
Federal certificate billing follows processing. Review of the additional Texas form can add operational lead time.
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.