Regulatory Science Symposium: Clinical Trials with Medical Devices Session 2: History, Terms/Definitions and Regulatory Requirements (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.


  1. Classes of Devices
  2. All Device Investigations
  3. Non-Significant Risk Study Examples
  4. Study-Determination or Pre-Submission
  5. Food and Drug Administration (FDA) Guidance on Non-Significant Risk (NSR) Study
  6. Office of Device Evaluation
  7. Primary Mode of Action
  8. Types of Clinical Trials
  9. Differences between types of Clinical Trials
  10. Consulting FDA
  11. Timelines
  12. More Information
  13. Investigational Device Exemption (IDE) Submission
    1. Device Information
    2. Non-Clinical Studies
    3. Risk Analysis
    4. Clinical Protocol
    5. Manufacturing Information – For Unmarketed Products
    6. Preparation
    7. Other Requirements
  14. Investigator’s Reporting Requirements
  15. Sponsor’s Reporting Requirements
  16. Changes without Approval
  17. Prior Approval Option
  18. Minor Changes go into the Annual Report
  19. Governing Regulations
  20. Hard to Find Subjects
    1. Inclusion Criteria
    2. Complex protocol
  21. Outcome Measures
  22. Single-patient Costs
  23. Specialized Clinical Designs
  24. Typical Features of Device Trials
  25. Clinical Research Associate/Clinical Research Coordinator (CRA/CRC)
  26. Adverse Event Reporting
  27. Top Five Problems of Recruitment and Retention in Early Device Trials
  28. Problems of Inexperienced Teams
  29. Special Problems of Surgical Interventions


Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy |


Frances Richmond, PhD
Director of the D. K. Kim International Center for Regulatory Science & Professor of Regulatory and Quality Sciences, Department of Regulatory and Quality Sciences, Mann School of Pharmacy

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