Readers will recall my previous post on the reorganization of CDRH to create a more adaptive structure to meet future needs. As part of that reorganization, the Office of Product Evaluation and Quality (OPEQ) was launched on May 1st, 2019 (see the announcement here). The announcement provides some practical examples of how the new structure worked during its pilot phase. The examples show how the collaborative nature of the new cross-functional teams worked to identify, resolve and communicate a safety issue and incorporate late breaking safety data into a change to an existing device. The announcement also discusses how the new structure contributes to the Total Product Lifecycle Concept and goals of the FDA’s Medical Device Safety Action Plan (see this previous post for details) and improves employee work life (consistent with CDRH’s strategic priorities). You may read more about the new office at its web page, and find out more about the reorganization plan at this page. If you are looking for where your CDRH contacts are now, take a look at the directory page, which will be updated as changes occur.

Text Copyright © 2019 Katrina Rogers