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  7. OCEA: Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality
  1. Center for Devices and Radiological Health

OCEA: Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality Also referred to as: OCEA


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 within the Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) provides policy and program support regarding clinical trial design and conduct, epidemiological and real-world evidence analyses, 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 epidemiologic analyses, as well as data infrastructure and expertise on clinical investigations and real-world evidence. 
  • Provide high-level programmatic support for Office of Health Technology (OHTs) engaging in total product life cycle review of devices.
  • Conduct outreach and collaboration with hospitals and other external stakeholders.
Who We Are

The Division of Clinical Evidence and Analysis 2 within the Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for biostatistics analysis in therapeutic and diagnostic biostatistics.    

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.

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.