The US Food and Drug Administration (FDA) on Monday finalized guidance to help device manufacturers meet the reporting and recordkeeping requirements for adverse events and malfunctions.

The 52-page question-and-answer-based guidance, first drafted in July 2013, supersedes that draft and other guidance from 1997.

“The goal is to detect and correct problems in a timely manner,” FDA said on Monday. “This guidance updates FDA’s policy and clarifies FDA’s interpretations of the regulatory requirements under part 803 (21 CFR part 803) and includes a section on common reporting errors.”

Background

Under the Medical Device Reporting (MDR) regulation, there is a mechanism that allows FDA and device manufacturers to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions of devices to detect and correct problems in a timely manner.

All manufacturers of legally marketed medical devices in the US, including foreign manufacturers who export devices to the US, are subject to the MDR regulation and must submit required reports.

A “manufacturer,” according to FDA, is any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure, including repackagers and device component or accessory manufacturers.

In addition, any person who reprocesses a single use device for reuse becomes the manufacturer of the device and is subject to all the requirements applicable to the original manufacturer, including the requirements of the MDR regulation, FDA says.

Types of Reports

Manufacturers are required to submit three types of MDR reports to FDA, each of which must be submitted within the mandatory time frame, including reports that:

• Must be submitted within 30 calendar days after the day a manufacturer becomes aware of a reportable device-related death or serious injury, or a reportable malfunction
• Must be submitted within five work days after the manufacturer becomes aware of an MDR reportable event, including one that necessitates remedial action to prevent an “unreasonable risk of substantial harm to public health” or one for which FDA has made a written request for
• Are supplemental or follow-up reports with information unknown or unavailable to manufacturers at the time of the initial 30-day report or 5-day report

However, for what FDA considers to be a device “user error” (or “use error”), which means a device-related error or mistake made by the person using the device, FDA says manufacturers are not required to submit an MDR report in some cases, but they should retain the supporting information in complaint files.

“Such errors often reflect problems with device labeling, the user interface, or other aspects of device design. Thus, FDA believes that these events should be reported in the same way as other adverse events which are caused or contributed to by the device. This is especially important for devices used in non-health care facility settings. If you determine that an event is solely the result of user error with no other performance issue, and there has been no device-related death or serious injury, you are not required to submit an MDR report, but you should retain the supporting information in your complaint files,” the guidance adds.

Reporting Events

Manufacturers, including foreign manufacturers, of legally marketed devices in the US are required to:

• Submit to FDA reports of MDR reportable events, which are “events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur”
• Develop, maintain, and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is a reportable event
• Establish and maintain complete files for all complaints concerning device events

FDA believes that manufacturers have a responsibility to inform all employees, including marketing, sales, engineering, manufacturing, regulatory, legal, installation and service personnel, to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Thus, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event.

The guidance also explains where device-related complaints come from, what a device malfunction is and when it must be reported, what a “serious injury” is, how to decide whether a malfunction is “likely to” cause or contribute to death or serious injury, cases where complaints might not have to be reported, information for contract device manufacturers and much more on specific issues and situations.

Medical Device Reporting for Manufacturers: Guidance for Industry and Food and Drug Administration Staff