- Auditing
- How do the FDA Audit?
- What happens after an Inspection?
- The Warning Letter to Ronald Wakai, PhD
- Monitoring, Auditing and Inspections
- Auditing and Monitoring to ensure Trial Quality
- Starting with a Good Audit Checklist
- Medical Device Clinical Trials
- Three Unique Features of Medical Device Clinical Trials
- A Significant Risk Study defined in 21 CFR 812
- Investigational Device Exemption (IDE) required for Human Study
- What IDE Permits? Exempts?
- Considerations for Different IDE Study Types
- Warning Letters for Medical Device Clinical Trials
- Warning Letters since 2013
- Risk-Based Monitoring of Medical Device Clinical Trials
- Monitoring Methods
- Risk-Based Monitoring (RBM)
- Clinical Monitoring with Quality
Benson Kuo, PhD
Associate Director, Regulatory Knowledge and Support