CLIA waiver state checklist
CLIA Certificate of Waiver requirements in Massachusetts for med spas and clinics.
Massachusetts laboratories performing exclusively CLIA-waived testing are exempt from the state clinical-laboratory license.
Last regulatory review 2026-07-24
This page is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device.
State-specific requirements checklist
- Federal CMS-116 Certificate of Waiver application.
- State clinical-laboratory licensure exemption for waived-only testing.
- Disease-reporting and other generally applicable Massachusetts requirements remain in force.
Fee and timing note
Federal Certificate of Waiver: $248 per two-year certificate. No separate Massachusetts clinical-laboratory license fee applies to an exclusively waived test menu.
Check my test menuPrep steps
- 1Confirm that the complete onsite menu remains CLIA-waived.
- 2Prepare CMS-116 and exact device evidence.
- 3Retain the Massachusetts exemption memorandum and reporting workflow in the compliance file.
Frequently asked questions
Does Massachusetts require more than the federal CLIA Certificate of Waiver?
Massachusetts laboratories performing exclusively CLIA-waived testing are exempt from the state clinical-laboratory license.
What extra steps does Massachusetts add for waived point-of-care testing?
Federal CMS-116 Certificate of Waiver application. State clinical-laboratory licensure exemption for waived-only testing. Disease-reporting and other generally applicable Massachusetts requirements remain in force.
How much does a CLIA waiver cost in Massachusetts and how long does it take?
Federal Certificate of Waiver: $248 per two-year certificate. No separate Massachusetts clinical-laboratory license fee applies to an exclusively waived test menu.
Does this page confirm CLIA approval or legal compliance in Massachusetts?
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.