Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in California
- A registration or license is automatically revoked 30 days after a major change of director or ownership unless a new application is filed within those 30 days.
- Owners and directors must notify CDPH in writing within 30 days of any change in ownership, director, name or location.
- For a pharmacy that registers, the pharmacist-in-charge counts as the laboratory director.
Does California require a state lab license on top of CLIA?
A lab working under a CLIA Certificate of Waiver or PPM certificate must register with CDPH; a lab running moderate or high complexity tests needs a state license. The owners and the laboratory directors apply before the lab opens, and each location needs its own registration or license.
- Clinical laboratory registration (waived or PPM); clinical laboratory license (moderate or high complexity)
- Issued by California Department of Public Health, Laboratory Field Services
- Reaches labs doing only waived tests
Citation: Cal. Bus. & Prof. Code 1265(a), (b), (d)
Who is exempt in California?
No physician office exemption. The chapter excludes federal labs (to the extent CMS modified CLIA for them), public health labs, forensic-only labs, research and teaching labs that do not report patient results, and a few narrow cases such as caregivers monitoring a diabetic child's glucose.
Citation: Cal. Bus. & Prof. Code 1241(b)
What does California charge?
License fees for moderate or high complexity labs run from $335 a year (under 2,001 tests) to $8,630 plus $420 per 500,000 tests over 1,000,000. Each additional location approved under BPC 1265(d)(2) costs $28 (BPC 1300(t)).
- Waived: $155 per year for a waived-only registration (as of October 2026)
- PPM: $235 per year for a PPM registration, or for waived plus PPM (as of October 2026)
Citation: Cal. Bus. & Prof. Code 1300(n), (t)
How often does a California lab registration renew?
- Renews every year
- Due One year from issue
Do labs in other states need a California license to test its specimens?
The chapter covers labs that receive specimens originating in California, wherever they sit, so an out-of-state lab testing California specimens needs a California license or registration and pays travel costs for any onsite inspection.
Citation: Cal. Bus. & Prof. Code 1241(a), 1300(q)
Does California add a form to the CMS-116?
The state registration or license application is separate from the CMS-116 and lists the tests, test kits, equipment, annual volume and the personnel's qualifications.
Where does a California CMS-116 go?
- California Department of Public Health, Laboratory Field Services
- Email: LFSCLIA@cdph.ca.gov
- Phone: (213) 620-6160
Opening a testing site in California?
We prepare the CMS-116 and any California filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.