On August 3, 2001 CBER issued a draft 510(k) guidance: “Premarket Notification Submissions forAutomated Testing Instruments Used in Blood Establishments”.

This guidance has many requirements related to software documentation to be submitted. One of the more interesting aspects of the guidance is the functional requirement for an electronic audit trai ” that automatically records all instrument/test run modifications and/or changes”.

The guidance is at the link provided and the comment period ends Nov 1, 2001.

SoftwareCPR keywords: Blood bank, establishment, BECS, IVD, analyzer