Medical Device Reporting is part of the Code of Federal Regulations - 21 CFR Part 803, mandated by Congress in 21 U.S.C. in 1976 to provide for federal oversight of medical devices. It establishes the reporting requirements for not only manufacturers, but also importers and user facilities and is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving marketed medical devices. It also helps to identify device problems that may be occurring across manufacturers and assists with trending analyses. Medical Device Reporting provides a method for user facilities to inform FDA and the manufacturer about problems they are seeing and experiencing. Medical Device Reporting is managed by the Center for Devices and Radiological Health (CDRH) at FDA. Other parts of the CFR interact with this portion of the regulation, including Part 806 - Corrections and Removals and part 820 - Good Manufacturing Practices.
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
By completing/passing this course, you will attain the certificate Medical Device Certificate
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