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.
- Provide human resource, travel, budget, facilities and other operational support for all OPEQ staff.
- IO: Immediate Office
- Office of Product Evaluation and Quality (OPEQ)