State filing guide
CLIA waiver application and requirements in California.
Ask about my application — no payment todayCalifornia requires a CDPH Clinical Laboratory Registration for waived-only testing as well as a federal CLIA Certificate of Waiver; the initial application is online with CMS-116 uploaded.
Sources checked 2026-10-31 · next source check due 2026-11-30
State authorization required
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.
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What the official sources say
- CDPH distinguishes registration for waived/PPMP testing from a clinical laboratory license for moderate/high complexity. Its CLIA page uses “license” generically; this waived-only proposal uses the registration category, subject to case review.
- Paper applications are no longer accepted. Start a new single-site application in the LFS online system, upload CMS-116 and pay the California registration fee there; Richmond LFS handles initial applications (LFScc@cdph.ca.gov).
- The current waived upload list requires LAB 182 for each owner and LAB 183 for each laboratory director. LAB 116 is listed only if PPMP; the single-site manual says waived sites do not need LAB 144A or portal analyte entry. Additional documents may be requested.
- LAB 183 requests a California Board license number or California Director license number. A federal waiver’s lack of director education/experience requirements does not establish California director or testing-personnel eligibility.
- The September 2026 CMS directory lists LFSCLIA@cdph.ca.gov, phone (213) 620-6160 and fax (213) 620-6565 at 320 W 4th St STE 890, Los Angeles CA 90013-2398. CDPH assigns this office federal certificate/fee inquiries, not initial online applications.
- CDPH places a 2–3 week CMS fee-coupon estimate after the state-registration step; it is not an end-to-end initial approval deadline. The old ClinicalLaboratoryFacilities page is obsolete and the old fee PDF returns HTTP 404.
Fees and timing
Effective January 1, 2026, CDPH publishes a $155 initial and annual waived-registration fee. State payment is in the online application; Visa, Mastercard and e-check are listed, and a card merchant service fee may be added (amount not verified). Federal Certificate of Waiver: $248 every two years, separately paid through Pay.gov after the electronic CMS fee coupon. Since March 1, 2026, paper federal coupons/certificates and checks have been discontinued. No total approval date is promised. Government fees are separate from preparation-service fees.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm the fixed single-site, own-patient physician-office facts and exact waived systems; changes, outside referrals, PPM/non-waived and special testing menus require separate review.
- 2Have the qualified reviewer confirm the registration selection, each owner/director attestation, California director and actual testing-personnel authority, and any additional live-portal uploads.
- 3Confirm the authorized human sender’s portal access, signature/representation policy, final government fees and receipt retention before filing. Consultant written confirmation is required before any service-coverage change.
Frequently asked questions
What filing route does the cited California guidance describe?
California requires a CDPH Clinical Laboratory Registration for waived-only testing as well as a federal CLIA Certificate of Waiver; the initial application is online with CMS-116 uploaded.
Which requirements are named in the cited California materials?
CDPH distinguishes registration for waived/PPMP testing from a clinical laboratory license for moderate/high complexity. Its CLIA page uses “license” generically; this waived-only proposal uses the registration category, subject to case review. Paper applications are no longer accepted. Start a new single-site application in the LFS online system, upload CMS-116 and pay the California registration fee there; Richmond LFS handles initial applications (LFScc@cdph.ca.gov). The current waived upload list requires LAB 182 for each owner and LAB 183 for each laboratory director. LAB 116 is listed only if PPMP; the single-site manual says waived sites do not need LAB 144A or portal analyte entry. Additional documents may be requested. LAB 183 requests a California Board license number or California Director license number. A federal waiver’s lack of director education/experience requirements does not establish California director or testing-personnel eligibility. The September 2026 CMS directory lists LFSCLIA@cdph.ca.gov, phone (213) 620-6160 and fax (213) 620-6565 at 320 W 4th St STE 890, Los Angeles CA 90013-2398. CDPH assigns this office federal certificate/fee inquiries, not initial online applications. CDPH places a 2–3 week CMS fee-coupon estimate after the state-registration step; it is not an end-to-end initial approval deadline. The old ClinicalLaboratoryFacilities page is obsolete and the old fee PDF returns HTTP 404.
What do the sources establish about fees and timing in California?
Effective January 1, 2026, CDPH publishes a $155 initial and annual waived-registration fee. State payment is in the online application; Visa, Mastercard and e-check are listed, and a card merchant service fee may be added (amount not verified). Federal Certificate of Waiver: $248 every two years, separately paid through Pay.gov after the electronic CMS fee coupon. Since March 1, 2026, paper federal coupons/certificates and checks have been discontinued. No total approval date is promised. Government fees are separate from preparation-service fees.
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.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
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From test research to your California application
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