Implementation of CDRH’s New Office of Product Evaluation and Quality.

This week the FDA announced the official implementation of the Office of Product Evaluation and Quality (OPEQ) within the FDA’s Center for Devices and Radiological Health (CDRH).  OPEQ has been established as a key step for the CDRH during the current period of reorganization.  The FDA hopes that this will help modernize business processes and assist in ensuring patients and health care providers have access to safe, effective, and quality medical devices.

The FDA hopes that the implementation of OPEQ will integrate the CDRH’s pre and postmarked program functions along product lines.  OPEQ has been structured to consolidate and integrate the current aspects of product review, quality, surveillance, and enforcement into an updated, team-based approach.  This should enable the FDA’s experts to utilize their knowledge to optimize decision-making during product life cycles.  The CDRH has been testing and refining OPEQ through a pilot system for the past year.

Moving forward, the industry should communicate with contact their current contacts in the CDRH and use the CDRH Management Directory to find the best contact for specific topics.  The FDA will continue the reorganization of the CDRh through September 2019 and update their website accordingly as any updates are implemented.

We will continue to monitor any future changes to the CDRH structure moving forward and post follow-up updates as they are announced.  If you have any questions about OPEQ and the FDA, how this will affect your company, or your regulatory requirement feel free to contact us at info@mdiconsultants.com or use our contact form re: OPEQ