State filing guide
Waived-testing filing requirements in New Jersey for med spas and clinics.
New Jersey requires both the federal CMS-116 Certificate of Waiver route and a state Clinical Laboratory License application for CLIA-waived tests only.
Official sources reviewed 2026-07-24 · review due 2026-08-23
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 New Jersey's cited terminology
- Federal CMS-116 Certificate of Waiver application.
- New Jersey CL-4 Application for Clinical Laboratory License (CLIA Waived Tests Only).
- The NJDOH CL-4 lists a $200 fee for an initial waived-only license application.
- List the exact waived test systems and retain the purchase and FDA waived-status evidence requested for the state packet.
Reviewed fee and agency-timing note
New Jersey's CL-4 lists a $200 fee for an initial state license application limited to CLIA-waived tests. The federal CLIA fee is separate: since March 1, 2026, CMS sends the fee coupon and certificate electronically, and federal fees must be paid online through Pay.gov; paper coupons, checks, and certificates are no longer accepted or mailed.
Check my test menuDated preparation steps
- 1Prepare CMS-116 with each waived analyte, test name, manufacturer, estimated annual test volume, and a valid shared email address for CMS electronic notices.
- 2Prepare the New Jersey CL-4 waived-only license application and the $200 initial state fee.
- 3Keep a device-specific FDA waived-status printout for every test system in your internal prep file.
Frequently asked questions
What filing route does the cited New Jersey guidance describe?
New Jersey requires both the federal CMS-116 Certificate of Waiver route and a state Clinical Laboratory License application for CLIA-waived tests only.
Which requirements are named in the cited New Jersey materials?
Federal CMS-116 Certificate of Waiver application. New Jersey CL-4 Application for Clinical Laboratory License (CLIA Waived Tests Only). The NJDOH CL-4 lists a $200 fee for an initial waived-only license application. List the exact waived test systems and retain the purchase and FDA waived-status evidence requested for the state packet.
What fee and agency-timing information was reviewed for New Jersey?
New Jersey's CL-4 lists a $200 fee for an initial state license application limited to CLIA-waived tests. The federal CLIA fee is separate: since March 1, 2026, CMS sends the fee coupon and certificate electronically, and federal fees must be paid online through Pay.gov; paper coupons, checks, and certificates are no longer accepted or mailed.
Does this page confirm CLIA approval or legal compliance in New Jersey?
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.