The FDA has released final guidance addressing reporting and record-keeping requirements for medical device manufacturers in the event of device-related adverse events and malfunctions.
“The goal is to detect and correct problems in a timely manner,” the FDA wrote in the final guidance document, which supersedes the draft published in 2013 and the guidance from 1997. Manufacturers, along with “medical device user facilities” like hospitals and outpatient treatment facilities, are directed to report adverse events and keep detailed records.
Under the Medical Device Reporting (MDR) regulation, found in part 803 of the Code of Federal Regulations, manufacturers of devices sold in the United States are required to submit a report to the FDA upon learning that their device “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.”
“MDR reportable events generally must be submitted to us within 30 calendar days after the day you become aware of the event,” the FDA continues. “Under some circumstances, a medical device report is required to be submitted within five work days after the day you become aware of the need to submit such a report.”
The document notes that in the case of use error, or “a device-related error or mistake made by the person using the device,” manufacturers are not always required to submit an MDR report; still, they should keep a record of the complain in their 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-healthcare 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,” according to the guidance.