FDA Reporting for Safer Medical Products

• Identify medical device reporting requirements of adverse events to the FDA and the manufacturer. 
• Describe the steps and requirements for reporting to the FDA  
• Discover how the FDA enforces Medical Device Reporting 

• FDA Medical Device Reporting 
• Legal Notice 
• Course Purpose and Learning Objectives 
• FDA MDR Background 
• MDR – Medical Device Reporting 
• Mandatory Medical Device Reporting 
• Who Are Mandatory Reporters? 
• Mandatory Medical Device Reporting: Manufacturer 
• Mandatory Medical Device Reporting: Importers 
• Mandatory Medical Device Reporting: Medical Device User Facility 
• FDA MedWatch Program 
• FDA MedWatch 
• FDA MDR Reporting Requirements 
• FDA MDR Other Reporting Requirements 
• MDR Reporting Requirements: User Facility 
• MDR Reporting Requirements: Manufacturer 
• FDA Enforcement of MDR Requirements 
• MedSun: Medical Product Safety Network 
• MedSun Program 
• AERS: Adverse Event Reporting System 
• Summary 
• End of Course Quiz 

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