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Who We Are

The Immediate Office within CDRH's Office of Product Evaluation and Quality (OPEQ) includes the following groups:

• Clinical and Scientific Policy Staff
• Quality and Analytics Staff
• Strategic Initiatives Staff
• Regulation, Policy and Guidance Staff
• Operations Staff

What We Do

Provides consistent interpretation and application of regulatory policy and guidance; assures implementation of CDRH and Agency strategic priorities; and operational support, strategy and oversight to the seven Offices of Health Technology, Office of Regulatory Programs and Office of Clinical Evidence.

Clinical and Scientific Policy Staff

• Clinical oversight and coordination for OPEQ clinical review programs.
• Provide clinical expertise in complex evaluations of medical devices.
• Communities of practice, and patient program development and oversight.
• Safety Signal Management Program development and coordination.
• Focal Point Program development and management.

Quality and Analytics Staff

• Oversee the consistent implementation of OPEQ and CDRH quality management system.
• Ensure the continuous process improvement of OPEQ's policies and practices.
• Responsible for serving as a strategic partner to the CDRH Quality Management group and assessing the overall performance of the organization.

Strategic Initiatives Staff

• Develop and drive strategic initiatives that cut across the OPEQ offices. 
• Provide change management support across OPEQ.

Regulations, Policy and Guidance Staff

• Provide authoritative advice and guidance to the OPEQ Director on regulatory policies, guidelines, issues and concerns that impact Office/Center program and initiatives.    

Operations Staff

• Provide human resource, travel, budget, facilities and other operational support for all OPEQ staff.

Office Organization

• IO:  Immediate Office
• Office of Product Evaluation and Quality (OPEQ)

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