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ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality


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 industry when interfacing with the various regulatory submission programs. 

Office Organization

Who We Are

The Division of Regulatory Programs 1 is responsible for programs involving premarket and other regulatory submissions, such as the510(k), PMA, HDE, DeNovo, Custom Device Exemption, 513(g), Third Party Submission, 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 programmatic expertise for the Third-Party Submission program to industry and all OPEQ staff.
Who We Are

The Division of Regulatory Programs 2 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.
Who We Are

The Division of Regulatory Programs 3 is responsible for device surveillance programs, such as the recalls, shortages, allegations of regulatory misconduct, and Medical Device Reporting (MDR) programs.

What We Do
  • Develop and implement policy and processes to ensure quality and consistency across programs impacting the continued safety of marketed devices.
  • Provide programmatic expertise for surveillance support programs to industry and FDA staff.
Who We Are

The Division of Regulatory Programs 4 is responsible for regulatory systems management, tools and templates development, and conducting analysis functions related to review performance and market intelligence across the total lifecycle of devices and products.

What We Do
  • Ensure development and deployment of systems, workflows and data structures that meet regulatory program requirements.
  • Implement guided regulatory review tools that promote simplicity and innovation for internal and external stakeholders.
  • Support device review programs by assessing performance and integrating data across premarket, postmarket and compliance sources.
  • Conduct forecasting analyses that assess market and economic indicators based on evoling industry, firm and device trends.

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 dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.




 
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