Late last year, the U.S. Food and Drug Administration released the final guidance on Medical Device Reporting (MDR), a critical quality component of a company’s complaint management system. This guidance explains and describes the current MDR regulations found in Title 21 CFR Part 803 while clarifying sections that were previously ambiguous. The new clarifications impact all manufacturers of legally marketed medical devices in the U.S. (including foreign manufacturers who export devices to the U.S.).
The final guidance requires manufacturers to submit reports if one of its marketed devices:
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- Caused, or contributed to a death or serious injury;
- Malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.
U.S. manufacturers of medical devices that are not cleared or approved in this country, but are exported to non-U.S. locations, are also subject to the MDR regulation. While the guidance still leaves some gray areas, it is clear the FDA is finally making it a priority to place more responsibility on the manufacturers when it comes to MDRs.
Reporting responsibilities
The FDA issued this guidance so that MDR responsibility falls on either device makers or the contract manufacturers. The FDA will now require that one of those two parties sign off with the agency to verify who is responsible if a device-related adverse event occurs. A manufacturer is any person who manufacturers, prepares or assembles a device. As the manufacturer, per the FDA, you are considered to have become aware of an event when:
- Any employee becomes aware of information that reasonably suggests that an event is required to be reported in the necessary time window;
- Any employee with management or supervisory responsibilities over regulatory, scientific or technical responsibilities or whose duties relate to the collection and reporting of adverse events becomes aware of a situation.
Report submission guidelines
Along with clarification on who is responsible for reporting, the final guidance also notes when reports need to be submitted. Under the new guidance, reports need to be submitted the moment anyone within an organization becomes aware of an adverse event.
The responsible party must:
- Submit within 30 calendar days of becoming aware of a reportable device-related death or serious injury, or a reportable malfunction.
- Submit within five working days of becoming 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 the FDA has made a written request.
Although it remains unclear what is enough to trigger a reportable event, manufacturers should hold themselves accountable for a quick and efficient timeline in reporting if they are responsible, or think they may be responsible. In more life-threatening situations, the threshold for five-day notifications on awareness is targeted towards company executives and managers.
Special cases
Another key clarification from the guidance was how special cases need to be handled from a reporting standpoint. In these cases, manufacturers must provide supplemental or follow-up reports with information unknown or unavailable to them at the time of the initial 30 or five-day report. Supplemental reporting is required when new facts prompt a manufacturer to alter any information or conclusions contained in the original report.
The case for automation
Prior to issuing this final guidance, the FDA had mandated electronic submission of reports in August 2015. While electronic report submission is as simple as hitting a button, creating reports still poses a challenge for some. Many companies are lagging in their implementation of automated systems and rely on manual or disjointed systems to create reports. This can prevent these businesses from adhering to report submission timeframes.
Additionally, it is important that manufacturers employ a consistent process and criteria for reporting. This can be facilitated through a centralized platform that can collect all information, and trigger alerts and workflows that ensure consistency throughout the organization. Most importantly, maintaining an auditable record of these events and subsequent actions can protect parties should an investigation arise.
Overall impact
While change is never easy, especially when it is related to the medical field, this guidance clarifies elements of the original guidance that have been unclear for more than a decade. As the industry changes and as technology advances, these guidelines will continue to evolve. That is why it is important for device makers and contract manufacturers to be proactive about their MDR processes, and adopt technologies that enable them to do so.
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