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  1. CDRH Offices

IO: Immediate Office, Office of Product Evaluation and Quality Also referred to as: IO


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