OFF-THE-SHELF SOFTWARE USED IN MEDICAL DEVICES REQUIRES HAZARD ANALYSIS, FDA SAYS IN DRAFT GUIDANCE; DOCUMENTATION AND LIFE-CYCLE CONTROL SHOULD REFLECT RISKS
This article was originally published in The Gray Sheet
Executive Summary
Medical device manufacturers that use off-the-shelf (OTS) software in their products are expected to perform a hazard analysis of the software as part of an overall system hazard analysis, FDA says in a recently released draft guidance on OTS device software.