The US Food and Drug Administration (FDA) has published final guidance on how to report and record adverse events and malfunctions for medical devices. This guidance was first published as a draft in July 2013.
Manufacturers who market their medical devices in the US must comply with the requirements of the Medical Devices Reporting regulation and are required to:
Submit the required reports within the appropriate mandatory timeframe.
Develop, maintain, and implement written procedures for the identification and evaluation of all medical device events to determine whether the event is an MDR reportable event
Establish and maintain complete files for all complaints concerning medical device events.
To access the full guidance document, please click here