- Classes of Devices
- All Device Investigations
- Non-Significant Risk Study Examples
- Study-Determination or Pre-Submission
- Food and Drug Administration (FDA) Guidance on Non-Significant Risk (NSR) Study
- Office of Device Evaluation
- Primary Mode of Action
- Types of Clinical Trials
- Differences between types of Clinical Trials
- Consulting FDA
- Timelines
- More Information
- Investigational Device Exemption (IDE) Submission
- Device Information
- Non-Clinical Studies
- Risk Analysis
- Clinical Protocol
- Manufacturing Information – For Unmarketed Products
- Preparation
- Other Requirements
- Investigator’s Reporting Requirements
- Sponsor’s Reporting Requirements
- Changes without Approval
- Prior Approval Option
- Minor Changes go into the Annual Report
- Governing Regulations
- Hard to Find Subjects
- Inclusion Criteria
- Complex protocol
- Outcome Measures
- Single-patient Costs
- Specialized Clinical Designs
- Typical Features of Device Trials
- Clinical Research Associate/Clinical Research Coordinator (CRA/CRC)
- Adverse Event Reporting
- Top Five Problems of Recruitment and Retention in Early Device Trials
- Problems of Inexperienced Teams
- Special Problems of Surgical Interventions
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