ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality Also referred to as: ORP
Who We Are
The Office of Regulatory Programs within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for developing policy and processes for core regulatory programs and provides programmatic expertise to Offices of Health Technology responsible for performing reviews of products over their total product lifecycle.
What We Do
- Manage the various regulatory programs across OPEQ, while providing high-level programmatic support for device specific offices engaging in total product life cycle review of devices.
- Provide programmatic expertise, develop policy interpretations and analysis, provide review processes and tools, and address novel or complex policy exceptions for purposes of ensuring consistency among device specific offices.
- Provide logistical support on document control, automated systems, quality assurance, and corrections to device submissions for device specific offices.
- Provide support to stakeholders utilizing OPEQ regulatory programs.
Office Organization
Who We Are
The Division of Regulatory Programs 1 within the Office of Regulatory Programs within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for programs involving premarket and other regulatory submissions, such as the510(k), PMA, HDE, DeNovo, Custom Device Exemption, 513(g), Presubmission and Medical Device Tracking programs.
What We Do
- Develop and implement policy and processes to ensure quality and consistency across the regulatory submission programs
- Provide programmatic expertise for regulatory submission programs to industry and staff
- Provide support to industry when interfacing with the various regulatory submission programs.
Who We Are
The Division of Regulatory Programs 2 within the Office of Regulatory Programs within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for establishment support programs, such as the imports, registration and listing, exports, regulatory inspections and audits, and quality and compliance programs.
What We Do
- Develop and implement policy and processes to ensure quality and consistency in assessment of medical devices and manufacturing establishments.
- Provide programmatic expertise for establishment support programs to industry and FDA staff.
- Provide support to industry when interfacing with the various establishment support programs.
Who We Are
The Division of Regulatory Programs 3 within the Office of Regulatory Programs within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the market intelligence programs, such as the recalls, shortages, allegations of regulatory misconduct, and Medical Device Reporting (MDR) programs. The division is also responsible for supporting analysis needs across various regulatory programs and across the total lifecycle of products and devices.
What We Do
- Develop and implement policy and processes to ensure quality and consistency across market intelligence programs impacting the continued safety of marketed devices.
- Provide programmatic expertise for market intelligence programs to industry and FDA staff.
- Provide support to stakeholders when interfacing with the various market intelligence programs
- Develop analytical tools and perform analyses for purposes of identifying and assessing product safety issues and targeting optimal use of resources.
Contact 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 [email protected] or 800.638.2041 or 301.796.7100.