CDRH Announces Implementation of Office of Product Evaluation and Quality

By MedTech Intelligence Staff

OPEQ is an important step in the center’s modernization of business processes.

This week CDRH officially launched the Office of Product Evaluation and Quality (OPEQ) as part of its reorganization, an effort to “adapt to future organizational, regulatory and scientific needs” that was announced in March.

OPEQ will integrate the premarket and postmarket program functions along products lines to help CDRH optimize decision making across the product lifecycle. This new, team-based structure consolidates and integrates current parts of product review, quality, surveillance and enforcement.

“OPEQ implementation is a key step in the Center’s reorganization that will help us both modernize business processes and even better fulfill our mission of ensuring patients and health care providers have continued access to safe, effective, and high-quality medical devices,” FDA stated in an agency release.

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