Announcing Implementation of CDRH's New Office of Product Evaluation and Quality
Today marks the official implementation of the new Office of Product Evaluation and Quality (OPEQ) at the FDA's Center for Devices and Radiological Health. 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.
Impact of OPEQ Implementation
OPEQ's implementation integrates CDRH's premarket and postmarket program functions along product lines, which enables our 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.
For the past year, CDRH has tested and refined this modern approach through the Office of Product Evaluation and Quality Pilot. For details on early successes with the new organizational structure, see Implementing a Team Based Approach to Medical Device and Radiological Product Evaluation and Quality.
Contacting CDRH
You should continue to communicate with your current contacts in CDRH or use the CDRH Management Directory to find the best Center contact for a specific topic. Implementation of OPEQ is one milestone in our CDRH reorganization.
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Questions?
If you have general questions about the reorganization or medical devices and radiological products, contact the Division of Industry and Consumer Education
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