CLSI EP22-P

Clinical and Laboratory Standards Institute document EP22-P–Presentation of a Manufacturer’s Risk Mitigation Information for Users of In Vitro Diagnostic Devices; Proposed Guideline provides guidance to manufacturers on the establishment and disclosure of information they might choose to share with users regarding the scope and effectiveness of device risk mitigations intended to prevent production or release of inaccurate patient test results. The information should include a description of the device feature or recommended user intervention intended to mitigate the risk, the targeted failure mode, and how the design mitigation feature or recommended user intervention works to ensure the quality of patient test results. This document does not address specific risk mitigation actions that might be performed by clinical laboratories beyond a manufacturer’s recommendations, nor does it describe or recommend risk assessment procedures or subsequent mitigations to be performed by in vitro diagnostic (IVD) device manufacturers.

This document is intended for IVD device manufacturers and gives guidance on the sharing of information with users who are responsible for the quality of laboratory output and must have knowledge of the strengths and limitations of the devices they use to make informed decisions about the scope and character of the quality control systems they apply.