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CLIA waiver state checklist
CLIA Certificate of Waiver requirements in Pennsylvania for med spas and clinics.
Pennsylvania: submit a Clinical Laboratory Permit Application and CLIA Application for Certification (CMS-116).
Last reviewed 2026-07-03
This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.
State overlay checklist
- Submit a Clinical Laboratory Permit Application and CLIA Application for Certification (CMS-116)
- State note: PA requires a minimum of 2 years of lab experience for a pharmacist to be a director
Fee and timing note
Plan for the federal CLIA certificate fee billed by CMS after processing, plus any Pennsylvania state application or license fee. Fee amounts change and are not quoted here — verify current CMS and state fees and processing time on the official state page before filing.
Check my test menuPrep steps
- 1Prepare CMS-116 with each waived analyte, test name, manufacturer, and estimated annual test volume.
- 2Keep a device-specific FDA waived-status printout for every test system in your internal prep file.
- 3Complete the Pennsylvania state application listed above before ordering in-house testing supplies.
- 4Confirm current fees and processing time with the Pennsylvania laboratory program (linked below) before you file.