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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.”
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.
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:
However, for what FDA considers to be a device “user
“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.
Manufacturers, including foreign manufacturers, of legally marketed devices in the US are required to:
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
Tags: device adverse events, reports on medical device malfunctions, FDA and device adverse events