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The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of their medical devices.
A medical device company must submit a Medical Device Report ("MDR") to the FDA to provide notice that it has become aware of an event that reasonably suggests that one of its marketed devices:
Depending on the circumstances, an MDR must be filed within:
The term "manufacturer" means any person who makes a device, including those who prepare, propagate compounds, assemble, or process devices by chemical, physical, biological or other procedures.
Additionally, a manufacturer is any person who:
A manufacturer is considered "aware of" a reportable event when any of its employees become aware of the event.
A manufacturer is also deemed "aware of" a reportable event when any of its employees who manage or supervise persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection of adverse events, become aware that remedial action is required to prevent an unreasonable risk of substantial harm to the public health.
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