CLSI EP22-P

Clinical and Laboratory Standards Institute document EP22-P–Presentation of a Manufacturer’s Risk Mitigation Informationfor Users of In Vitro Diagnostic Devices; Proposed Guideline provides guidance to manufacturers on the establishment anddisclosure of information they might choose to share with users regarding the scope and effectiveness of device risk mitigationsintended to prevent production or release of inaccurate patient test results. The information should include a description of thedevice feature or recommended user intervention intended to mitigate the risk, the targeted failure mode, and how the designmitigation feature or recommended user intervention works to ensure the quality of patient test results. This document does notaddress specific risk mitigation actions that might be performed by clinical laboratories beyond a manufacturer’srecommendations, nor does it describe or recommend risk assessment procedures or subsequent mitigations to be performed by invitro diagnostic (IVD) device manufacturers.

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

Published:

01/01/2010

ISBN(s):

1562387170

Number of Pages:

56