Certificate of Waiver

6006.2 – Certificate of Waiver (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) A Certificate of Waiver (CoW) is issued to a laboratory that performs only tests categorized as waived tests and pays the appropriate fee. Waived tests are those that have been determined to be so simple that if performed incorrectly will pose no risk of harm. The initial list of tests approved for CoW status are listed at 42 CFR 493.15, however, the list has been extended and can be viewed at accessdata.fda.gov. A CoW is valid for a 2-year period. Upon certificate expiration, and after payment of appropriate fees, the laboratory’s certificate will be renewed for another 2-year period. While the laboratory with a CoW is not subject to routine inspections, the laboratory must comply with CLIA registration and certificate requirements and follow the manufacturer’s instructions for test performance. Laboratories with a CoW may be subject to a complaint investigation by State Agency (SA) surveyors or CMS.