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
- OPEQ implements 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.
- OPEQ protects and promotes 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.
- OPEQ fosters a culture of quality within an ever‐expanding global medical device market.
- OPEQ is 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).
- OPEQ fosters the development of methodology, analysis, and clinical trial infrastructure to facilitate the assessment of medical device safety and effectiveness.
- OPEQ administers the federal law that supports the clinical laboratory community (the Clinical Laboratory Improvement Amendments—CLIA).
- OPEQ also regulates radiation-emitting non-medical products.
- OPEQ implements the Mammography Quality Program authorized by the Federal Mammography Quality Standards Act of 1992.
- Collaboratively support CDRH in assuring the enforcement of the Medical Device Amendments of 1976 including the Safe Medical Devices Act of 1990 and 1992, the Food and Drug Administration Modernization Act and the Radiation Control for Health and Safety Act of 1972 relating to the safety and effectiveness of medical devices and radiation-emitting electronic products.
- 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 to the overall strategy and priorities of CDRH and the Food and Drug Administration (FDA).
- Office of Product Evaluation and Quality (OPEQ)
- 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 and Radiological Health
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 email@example.com or 800.638.2041 or 301.796.7100.