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  1. CDRH Offices

OCEA: Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality

Who We Are

The Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.

What We Do

  • Provide policy and program support for clinical evidence and human subject protection.
  • Support device reviews that require expert clinical investigation and real-world evidence analysis.
  • Provide regulatory oversight of medical device clinical investigations, good laboratory practice (GLP), and good clinical practice (GCP) issues in support of premarket review.
  • Provide biostatistical and epidemiologic analyses, as well as support in the development of data infrastructure and expertise on clinical investigations and real-world evidence.
  • Provide programmatic support for Offices of Health Technology (OHTs) engaging in total product life cycle review of devices.
  • Conduct outreach and collaboration with hospitals and other external stakeholders.

Office Organization

Who We Are

The Division of Clinical Evidence and Analysis 1 (Division of Clinical Policy and Quality) is responsible for developing policy and providing support for programs involving clinical evidence, such as IDE and Clinical Trials, Breakthrough Devices, Safer Technologies Program (STeP), Real-World Evidence, Postmarket Mandated Studies, and Bioresearch Monitoring (BIMO).

What We Do

  • Develop and implement policy and processes to ensure quality and consistency across the Offices of Health Technology (OHTs) engaging in total product life cycle review of devices.
  • Provide programmatic expertise for regulatory submission programs to industry and staff
  • Conduct BIMO activities to ensure the quality and integrity of data submitted to the Agency and to provide for protection of the rights and welfare of research participants in accordance with GCPs and GLPs

Who We Are

The Division of Clinical Evidence and Analysis 2 (Division of Clinical Evidence Outreach) is responsible for epidemiological and real-world evidence infrastructure development, study design, methods, and analysis and outreach and collaboration with hospitals and other external stakeholders.

What We Do

  • Coordinate with stakeholders on the development of infrastructure novel methodology for generating real-world evidence.
  • Provide epidemiologic analysis and interpretation for real-world studies.
  • Ensure the safety of marketed devices through development of methods for post-market surveillance and conduct of real-world evidence based post-market safety studies.

Who We Are

The Divisions of Clinical Evidence and Analysis 3, 4, and 5 (Division of Biostatistics I, II, and III, respectively) are responsible for developing, implementing, and promoting innovative statistical methodology for study design and analysis of clinical evidence generated throughout the total product life cycle of a medical device.

What We Do

  • Ensure the safety and effectiveness of medical devices through pre-market and postmarket statistical review to:
    • Determine the validity of sponsor’s statistical analyses and interpretability of results.
    • Assess the robustness of results to check impact of assumptions, potential sources of bias, and missing data.
    • Present and discuss reviews at advisory committee meetings.
  • Provide leadership and statistical support for CDRH and FDA programs.
  • Develop and disseminate statistical policy and guidance.
  • Conduct independent research on statistical methodologies to support CDRH’s regulatory review process.
  • Promote the use of sound statistical methodology through publications, conferences, and internal and external training.

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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