CLIA waiver state checklist
CLIA Certificate of Waiver requirements in Nevada for med spas and clinics.
Nevada requires state laboratory authorization in addition to the federal CLIA pathway; the clinic must be classified for qualifying exempt registration versus general laboratory licensure.
Last regulatory review 2026-07-29
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
- Nevada exempt-laboratory registration only when the physician-operated laboratory satisfies NRS 652.072 and NAC 652.155; otherwise general laboratory licensure applies.
- Federal CMS-116 Certificate of Waiver application.
- Director qualification review under the applicable Nevada laboratory category.
Fee and timing note
Federal Certificate of Waiver: $248 per two-year certificate. Effective July 1, 2026, Nevada's initial qualifying exempt-laboratory registration fee is $535. Other laboratories use the general license schedule, which starts at $1,177 initially for annual test volume below 25,000 and increases by volume. Classify the facility before quoting a state fee.
Check my test menuPrep steps
- 1Confirm ownership, physician-operation, patient relationship, test menu, annual volume, and director facts before selecting exempt registration or general licensure.
- 2Prepare the applicable Nevada state application and CMS-116 only after that classification is documented.
- 3Reconfirm the current form, fee, and manual submission channel immediately before filing.
Frequently asked questions
Does Nevada require more than the federal CLIA Certificate of Waiver?
Nevada requires state laboratory authorization in addition to the federal CLIA pathway; the clinic must be classified for qualifying exempt registration versus general laboratory licensure.
What extra steps does Nevada add for waived point-of-care testing?
Nevada exempt-laboratory registration only when the physician-operated laboratory satisfies NRS 652.072 and NAC 652.155; otherwise general laboratory licensure applies. Federal CMS-116 Certificate of Waiver application. Director qualification review under the applicable Nevada laboratory category.
How much does a CLIA waiver cost in Nevada and how long does it take?
Federal Certificate of Waiver: $248 per two-year certificate. Effective July 1, 2026, Nevada's initial qualifying exempt-laboratory registration fee is $535. Other laboratories use the general license schedule, which starts at $1,177 initially for annual test volume below 25,000 and increases by volume. Classify the facility before quoting a state fee.
Does this page confirm CLIA approval or legal compliance in Nevada?
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.