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

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 | ashtekar@usc.edu