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).
- 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 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 firstname.lastname@example.org or 800.638.2041 or 301.796.7100.