The FDA this week issued a new draft guidance on how the agency regulators adverse event reporting for medical devices, seeking to revise rules last updated in March 1997.
The new guidance document is lengthy and extensive, covering frequently asked questions as well as common reporting errors committed by medical device makers, according to the FDA.
Among the most frequent reporting errors, the FDA noted that some device makers mistakenly include multiple devices or multiple adverse events in the same report.
"If more than one of your devices is involved in a single MDR reportable event, and it is not apparent which device may have caused or contributed to the event, then you must submit a separate report for each of your devices involved in the event," according to the FDA notice. "If a series of MDR reportable events occurs, then you must submit a separate report for each event."
The FDA also asked that reporters make sure to fill in as much information as they can, rather than leaving parts of the form blank, and that reporters ensure that they provide contact names and telephone numbers, among other tips.
The official public commenting period for the new draft guidance is open for 90 days from the time of the initial announcement, dated July 9, 2013.
Original medical device reporting rules were put in effect in December 1984, mandating that all medtech importers and manufacturers report adverse events, which are defined as "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."
