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 In this section:

                CDRH Offices

CDRH Offices
            
                        Office of the Center Director
          Office of Communication and Education
          Office of Management
          Office of Policy
          Office of Product Evaluation and Quality
          Office of Science and Engineering Laboratories
          Office of Strategic Partnerships and Technology Innovation Home
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          Center for Devices and Radiological Health
          CDRH Offices
          Office of Product Evaluation and QualityCDRH Offices Office of Product Evaluation and Quality
    Also referred to as: OPEQ

    
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*William (Bill) Maisel, M.D., MPH. Director,
Office of Product Evaluation and Quality (OPEQ)*

Who We Are

The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) assures patients have access to high quality, safe and effective products throughout the total product lifecycle.

What We Do

Implement the program areas through which medical devices are evaluated or cleared for clinical investigations and marketing, such as Premarket Notification (510(k)), Premarket Approval Applications (PMA), Investigational Device Exemptions (IDEs), Humanitarian Device Exemption (HDE), De Novo and Product Development Protocols (PDPs) programs.
	Protect and promote the public health by evaluating, enhancing and ensuring compliance with medical device laws through the Recall, Inspection and Audit, Registration & Listing, Allegations of Regulatory Misconduct, Import, Export, Premarket and Labeling, and Bioresearch Monitoring programs.
	Foster a culture of quality within an ever‐expanding global medical device market.
	Responsible for ensuring the continued safety and effectiveness of medical devices after they have reached the market place through robust epidemiological programs and analysis of medical device reports (MDRs).
	Foster the development of methodology, analysis, and clinical trial infrastructure to facilitate the assessment of medical device safety and effectiveness.
	Administer aspects of the federal law that supports the clinical laboratory community (the Clinical Laboratory Improvement Amendments—CLIA).
	Regulate radiation-emitting non-medical products.
	Implement the Mammography Quality Program authorized by the Federal Mammography Quality Standards Act of 1992.
	Set strategy and oversee device specific clinical evidence and analysis, and regulatory functions and programs activities to ensure quality end-to-end device evaluation, and the consistent interpretation and application of regulatory policy and guidance.
	Ensure that these functions and program activities are aligned with the overall strategy and priorities of CDRH and the Food and Drug Administration (FDA).Office Organization

OPEQ Immediate Office
	ORP: Office of Regulatory Programs
	OCEA: Office of Clinical Evidence and Analysis
	OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Device
	OHT2: Office of Cardiovascular Devices
	OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
	OHT4: Office of Surgical and Infection Control Devices
	OHT5: Office of Neurological and Physical Medicine Devices
	OHT6: Office of Orthopedic Devices
	OHT7: Office of In Vitro Diagnostics
	OHT8: Office of Radiological HealthAdditional Resources

Reorganization of The Center for Devices and Radiological HealthContact Us

For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization.

For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.

                                                                                  Content current as of:
      02/28/2023CDRH Offices
            
          
                        Office of the Center Director
          Office of Communication and Education
          Office of Management
          Office of Policy
          Office of Product Evaluation and Quality
          Office of Science and Engineering Laboratories
          Office of Strategic Partnerships and Technology Innovation
 
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