U.S. FDA Medical Device Reporting Requirements

The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. This FDA medical device reporting course provides critical information to ensure mandatory reporters maintain compliance with the regulation.

At the end of this module, you will be able to:

• Identify who must report adverse events to FDA
• Recognize how to report adverse events to FDA
• Identify various types of reportable adverse events
• Identify timeframes for reporting
• Recognize how FDA utilizes adverse event reports
• Define exemptions to reporting adverse events

This course is important for medical device professionals, especially to those who conduct or participate in any project and/or quality systems activities.

By completing/passing this course, you will attain the Medical Device Certificate.