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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.

This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.

State overlay 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.
  • Budget for a state filing fee and verify current CDPH fee schedules before launch.

Fee and timing note

Expect federal certificate billing after processing plus California registration review. Older NCPA/CDA references cite about $113 for the state filing fee; verify current CDPH fees.

Check my test menu

Prep steps

  1. 1Prepare CMS-116 with each waived analyte, test name, manufacturer, and estimated annual volume.
  2. 2Prepare California registration materials before ordering in-house testing supplies.
  3. 3Keep a device-specific FDA waived-status printout for each test system.

Sources to verify

CDPH Clinical Laboratory FacilitiesNCPA state CLIA-waiver workbook