Medical Device Reports (MDRs)

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.

What is an MDR?

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:

• May have caused or contributed to a death or serious injury; or
• Has malfunctioned and the device or a similar device marketed by the company would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

When Must an MDR Be Filed?

Depending on the circumstances, an MDR must be filed within:

• Thirty days after the date the manufacturer received or became aware of information that reasonably suggests that the device: (1) may have caused or contributed to a death or serious injury or (2) could do so if a similar malfunction were to recur.
• Five days after: (1) the date the manufacturer became aware that remedial action is necessary to prevent an unreasonable risk of substantial harm to the public health or (2) the FDA makes a written request for submission of a report.

Who is a "Manufacturer"?

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:

• Repackages or changes the container, wrapper, or labeling of a device in the process of distributing it;
• Initiates specifications for and ultimately distributes a device that is manufactured by a second party;
• Acts as the U.S. agent of a foreign manufacturer; or
• Manufactures components or accessories that are devices ready to be used and are intended to be commercially distributed and will be used "as is" by a licensed practitioner or other qualified person to meet the needs of a particular patient.

When Is a Manufacturer Considered "Aware Of" an MDR-Reportable Event?

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.