CLIA waiver state checklist
CLIA Certificate of Waiver requirements in New York for med spas and clinics.
New York is CLIA-exempt: use the NYS DOH/CLEP Limited Service Laboratory registration instead of filing a separate federal CMS-116.
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
- Initial Limited Service Laboratory Registration (DOH-4081) through NYS Wadsworth/CLEP.
- The initial or reapplication fee is $200 and is non-refundable.
- Registrants may perform only tests listed on the issued registration certificate.
- Registration certificates are valid for two years from issuance.
Fee and timing note
NYS Wadsworth lists a $200 non-refundable initial or reapplication fee. The state-issued registration is valid for two years, and Wadsworth asks applicants to allow a minimum of three weeks after receipt. New York's CLIA-exempt route has no separate federal CMS-116, e-coupon, or federal Certificate of Waiver fee.
Check my test menuPrep steps
- 1Build the exact test menu before submitting the Limited Service Laboratory packet.
- 2Confirm whether the practice type and director qualifications fit the limited-service route.
- 3Prepare DOH-4081 with the $200 state fee; do not prepare a separate CMS-116 or federal CLIA payment.
- 4Keep FDA waived-status evidence in the internal prep file.
Frequently asked questions
Does New York require more than the federal CLIA Certificate of Waiver?
New York is CLIA-exempt: use the NYS DOH/CLEP Limited Service Laboratory registration instead of filing a separate federal CMS-116.
What extra steps does New York add for waived point-of-care testing?
Initial Limited Service Laboratory Registration (DOH-4081) through NYS Wadsworth/CLEP. The initial or reapplication fee is $200 and is non-refundable. Registrants may perform only tests listed on the issued registration certificate. Registration certificates are valid for two years from issuance.
How much does a CLIA waiver cost in New York and how long does it take?
NYS Wadsworth lists a $200 non-refundable initial or reapplication fee. The state-issued registration is valid for two years, and Wadsworth asks applicants to allow a minimum of three weeks after receipt. New York's CLIA-exempt route has no separate federal CMS-116, e-coupon, or federal Certificate of Waiver fee.
Does this page confirm CLIA approval or legal compliance in New York?
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.