For how long is a CLIA waiver valid?

A CLIA waiver is valid for two years. This two-year validity period is significant as it aligns with periodic updates to laboratory testing regulations and requirements, ensuring that laboratories maintain compliance with standards set for waived testing. After this period, a laboratory must renew its waiver to continue performing tests that fall under the Clinical Laboratory Improvement Amendments (CLIA) without additional regulatory burdens imposed on higher complexity testing. This renewal process helps ensure that laboratories remain informed about any changes in practices or protocols that may affect testing quality and safety.