When does a CLIA renewal start?
For a Certificate of Compliance, the renewal application is due 9 to 12 months before expiration, and CMS's March 2026 guide says the survey-fee invoice goes out about one year before expiration. For a Certificate of Accreditation, the same federal rule says 9 to 12 months, while that guide says the renewal invoice goes out about six months before expiration. A CLIA certificate is valid for no more than two years. Confirm the current instruction with your state agency before you rely on a date.
The two clocks
The regulation and the CMS guide are both current public documents. They do not describe the same moment. Read your certificate type across the row.
| Certificate | 42 CFR, as on eCFR | CMS guide, March 2026 |
|---|---|---|
| Compliance | Valid for no more than 2 years. A laboratory seeking to renew must return the renewal application 9 to 12 months before expiration. 42 CFR 493.49(d) and (g). | Survey-fee invoice about one year before expiration. Certificate-fee invoice after the compliance survey. |
| Accreditation | Valid for no more than 2 years. A laboratory seeking to renew must return the renewal application 9 to 12 months before expiration. 42 CFR 493.61(d) and (h). | Renewal invoice about six months before expiration. |
| Waiver | A laboratory seeking to renew must return the renewal application not less than 9 months and not more than 1 year before expiration. 42 CFR 493.37(f). | Renewal invoice about six months before expiration. Grouped in the guide with accreditation and PPM. |
| PPM | Valid for no more than 2 years. Section 493.47, as reviewed, does not repeat the 9-to-12-month application sentence used for Compliance and Accreditation. 42 CFR 493.47(e). | Renewal invoice about six months before expiration. |
A Certificate of Registration is different. It is valid for no more than two years or until an inspection, whichever is shorter, and it is not renewable. It may be reissued if compliance has not been determined before it expires. 42 CFR 493.45(e).
What state agencies tell laboratories
On the pages reviewed for this article, Tennessee and South Carolina both say an active certificate renews when the laboratory pays the CMS fee coupon. They say a new application is for a change, or for a certificate that has been allowed to expire, not for a routine renewal.
- Tennessee: changes and the renewal process. The page says renewal is an automated CMS process and that an application is not necessary unless the certificate has expired. It lists a Compliance survey fee 12 months before expiration and a certificate fee after the survey, and a coupon 6 months before expiration for Waiver, PPM, and Accreditation.
- South Carolina CLIA FAQs. The FAQ says facilities with an active certificate are not required to submit a renewal application. Billing starts between 6 months and 1 year before expiration, on the same split: 6 months for Waiver, PPM, and Accreditation; 1 year for the Compliance survey fee, then a second bill for the certificate after the survey.
Your state agency can differ. The CMS-116 form tells laboratories to send the completed application to the state agency, not to CMS, and not to send payment with the form. Form CMS-116 (PDF).
When a CMS-116 is the action
Use Form CMS-116 for a new certificate, a change the state agency says needs an application, or a certificate that has lapsed and has to be restarted. In Texas, the state agency also requires Form 3225, a supplement to CMS-116, before it will process a CLIA application. That is an application rule, not a biennial renewal calendar. Texas HHSC CLIA.
This page does not list certificate fees. The CMS fee-schedule PDF reviewed on the same day is labeled version 1/9/2019, and 42 CFR 493.638 says the amount due is the figure in the latest Federal Register notice when the renewal is processed. A fee on this page would go stale.
Paper coupons and certificates
The CMS CLIA page says CLIA has moved to a paperless system: CMS no longer mails certificates or paper fee coupons, certification and survey fees are paid online at pay.gov, and the laboratory needs a valid email address on file to receive them. The Texas HHSC page says that after March 1, 2026, paper fee coupons and CLIA certificates will no longer be available, and laboratories switch to email notifications to receive them. If the email on file is wrong, the coupon and the certificate go to the wrong place. That change is reported to the state agency.
What this page does not decide
The Deadline Desk is an independent service. It is not CMS, HHS, or your state agency, and this page is not a determination for your laboratory. The dates above are what those sources said when they were read. Your state agency’s current instruction controls the filing.
If you want the dates we can see in public CMS records for your own CLIA number, including which clock applies to that certificate, use the free check. We never ask for patient data.
Sources
- 42 CFR 493.49 — Certificate of Compliance, including 493.49(g). eCFR, read 8 October 2026.
- 42 CFR 493.61 — Certificate of Accreditation, including 493.61(h). Read 8 October 2026.
- 42 CFR 493.37(f) — Certificate of Waiver renewal application. eCFR, read 8 October 2026.
- 42 CFR 493.47 — Certificate for PPM procedures. eCFR, read 8 October 2026.
- 42 CFR 493.45(e) — Registration certificate is not renewable. eCFR, read 8 October 2026.
- CLIA Certification Quick Start Guide — CMS, March 2026. Invoice timing by certificate type.
- Clinical Laboratory Improvement Amendments (CLIA) — CMS. Paperless certificates and pay.gov. Read 8 October 2026.
- Tennessee changes and renewal process. Read 8 October 2026.
- South Carolina CLIA FAQs. Read 8 October 2026.
- Form CMS-116 and Texas Form 3225. Read 8 October 2026.
Last verified 8 October 2026. Owner: Joel Shakespear. Re-read the eCFR sections, the CMS Quick Start Guide, and the state pages each quarter, and before any fee is added here.