FDA Medical Device Reporting

Course Details:

• Category: Clinical
• Duration: 15 minutes
• Target Audience: All Employees

Course Overview: Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical Device Reporting (MDR) is one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Training Includes:

• Types of Monitoring from the FDA
• FDA Inspections
• Device Performance
• Potential safety issues
• Risk assessments
• Reporting Requirements
• Medwatch Forms