State filing guide
Waived-testing filing requirements in Pennsylvania for med spas and clinics.
Pennsylvania requires a state clinical-laboratory permit packet in addition to CMS-116.
Official sources reviewed 2026-08-13 · review due 2026-09-12
This dated guide is educational. It does not confirm approval, legal compliance, applicability to a specific facility, or waived status for any device.
Requirements using Pennsylvania's cited terminology
- Pennsylvania Clinical Laboratory Permit application and Appendix B.
- Federal CMS-116 Certificate of Waiver application.
- Director documentation required by the current state packet.
Reviewed fee and agency-timing note
Federal Certificate of Waiver: $248 per two-year certificate. Pennsylvania lists a $100 initial permit fee and asks applicants to allow at least four weeks; annual renewal fees are invoiced.
Check my test menuDated preparation steps
- 1Prepare the current Pennsylvania permit application, Appendix B, and director evidence.
- 2Prepare CMS-116 and exact waived test systems.
- 3Submit the combined packet with the $100 initial state fee.
Frequently asked questions
What filing route does the cited Pennsylvania guidance describe?
Pennsylvania requires a state clinical-laboratory permit packet in addition to CMS-116.
Which requirements are named in the cited Pennsylvania materials?
Pennsylvania Clinical Laboratory Permit application and Appendix B. Federal CMS-116 Certificate of Waiver application. Director documentation required by the current state packet.
What fee and agency-timing information was reviewed for Pennsylvania?
Federal Certificate of Waiver: $248 per two-year certificate. Pennsylvania lists a $100 initial permit fee and asks applicants to allow at least four weeks; annual renewal fees are invoiced.
Does this page confirm CLIA approval or legal compliance in Pennsylvania?
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.