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FDA announces implementation of CDRH’s new Office of Product Evaluation and Quality

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has officially opened the new Office of Product Evaluation and Quality (OPEQ) at the FDA’s Center for Devices and Radiological Health (CDRH). OPEQ implementation is a key step in the Center’s reorganization that is planned to help both modernize business processes and better fulfill the mission of ensuring patients and health care providers have continued access to safe, effective, and high-quality medical devices.

OPEQ’s implementation integrates CDRH’s premarket and postmarket program functions along product lines, which enables FDA experts to leverage their knowledge to optimize decision-making across the product life cycle. This type of structure consolidates and integrates many of the current aspects of product review, quality, surveillance and enforcement into a new, team-based approach.

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