CLIA waiver state checklist
CLIA Certificate of Waiver requirements in California for med spas and clinics.
Federal CMS-116 plus California Laboratory Field Services registration for waived testing.
Last regulatory review 2026-07-24
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
- Clinical Laboratory Registration for waived or PPMP testing through CDPH Laboratory Field Services.
- LAB 155 and director attestation materials are commonly part of the state packet.
- CDPH lists a $155 fee for an initial waived registration and for a renewal expiring on or after January 1, 2026.
Fee and timing note
California's waived-registration fee is $155 for an initial registration or a renewal expiring on or after January 1, 2026. The federal CLIA cycle is separate: since March 1, 2026, CMS sends the fee coupon and certificate electronically, and federal fees must be paid online through Pay.gov; paper coupons, checks, and certificates are no longer accepted or mailed.
Check my test menuPrep steps
- 1Prepare CMS-116 with each waived analyte, test name, manufacturer, estimated annual volume, and a valid shared email address for CMS electronic notices.
- 2Prepare California registration materials before ordering in-house testing supplies.
- 3Keep a device-specific FDA waived-status printout for each test system.
Frequently asked questions
Does California require more than the federal CLIA Certificate of Waiver?
Federal CMS-116 plus California Laboratory Field Services registration for waived testing.
What extra steps does California add for waived point-of-care testing?
Clinical Laboratory Registration for waived or PPMP testing through CDPH Laboratory Field Services. LAB 155 and director attestation materials are commonly part of the state packet. CDPH lists a $155 fee for an initial waived registration and for a renewal expiring on or after January 1, 2026.
How much does a CLIA waiver cost in California and how long does it take?
California's waived-registration fee is $155 for an initial registration or a renewal expiring on or after January 1, 2026. The federal CLIA cycle is separate: since March 1, 2026, CMS sends the fee coupon and certificate electronically, and federal fees must be paid online through Pay.gov; paper coupons, checks, and certificates are no longer accepted or mailed.
Does this page confirm CLIA approval or legal compliance in California?
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.