Tom Middleton, Solutions Architect, Sparta Systems
In November 2016, FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how to do things. It is organized as an FAQ-style reference, to be used in conjunction with online Medical Device Reporting requirements and guidelines.
This 46-page document is welcomed outreach from FDA to help the industry through the reporting process. There have been some gray areas with MDR submissions for a number of years. Manufacturers had multiple questions and challenges in terms of gathering data and understanding the requirements for varied scenarios. FDA clearly hopes that this document will help standardize a manufacturer’s approach, and provide support and clarity for unusual scenarios. Used appropriately, the guidance should make the process cleaner for manufacturers.
FDA has been building the guidance document for a number of years using questions they’ve heard from the industry, such as:
- How is “when you become aware” of an adverse event actually defined by FDA?
- What’s considered a serious event or a serious injury that would necessitate an event being reportable?
- When does a complaint concerning a device manufactured by my company not have to be reported?
- What are the stipulations that would make a complaint not reportable?
- What are the types of reports that could be out there?
- What are the criteria for 30-day reports or 5-day reports and the supplemental/follow-up reports? What defines these?
Think of the guidance as a supplemental document to the MDR requirements. Guidance documents explain what needs to be done and (perhaps most importantly) review the intent of the required steps. This can help alleviate confusion. The following sections answer some of the questions We’ve had from clients on subjects such as electronic submissions, the link between device labeling and adverse events, and, of course, when to report.
In 2016, FDA made electronic submission of adverse events mandatory, as opposed to a choice between electronic and paper submissions. A valuable aspect of the guidance document is that it provides a resource companion for electronic submissions, even answering some of the simple but frustrating questions related to the FDA website, for example. Making the switch from paper to electronic is a cumbersome undertaking. Many manufacturers have had to adapt their processes to meet the new requirement, and some are still adjusting to the process. Troubleshooting for electronic submission is built into the guidance.
There are lingering questions about whether device manufacturers are required to report an adverse event if a label lists a possible event as a risk. In devices, even labeled risks could result in an injury. FDA says quite clearly in the new document that such events are indeed reportable. If an adverse event occurs, it does not matter whether the event came with a warning.
When and how to report
The first determination that manufacturers should make is whether the event is considered a reportable event. The second question is when, or how soon, must you report? The answers to these questions don’t necessarily come in that order. The first thing you need to determine is the date that anyone in an organization— an employee, a contractor, a sales rep, or customer service rep—became aware of information that reasonably links the event with the company’s medical device. That moment starts the clock for a 30-day submission.
The 5-day window
However, for serious events there are stipulations that could require the report to be made within five (5) days instead of thirty (30). The five-day window is based on working days, as opposed to calendar days. The five-day window kicks off when someone within the company’s organization who is knowledgeable about adverse events makes a judgement call. It might be management or a supervisor that can make the appropriate assessment that this adverse event is a serious event and could potentially require a recall or some type of remediation.
FDA’s new MDR document delves deeply into making these determinations. It answers the question of how to define a serious injury that necessitates the five-day window. It clarifies that if something is considered life threatening, causes permanent impairment, or requires medical or surgical intervention, it is to be determined a serious event. An event is also considered serious if there is a reason to take immediate action on the product or repair or rework the product to prevent recurrence.
To report or not report
To aid in determining whether an event is reportable or not reportable, FDA has provided a questionnaire to help you arrive at an answer quickly. But, most importantly, every complaint must be investigated and a determination made, and documented— as to whether an event needs to be reported or not reported. You must show your work.
Some circumstances that might not require a report include those where it can be reasonably concluded that your device did not cause or contribute to death or injury. Sometimes adverse events are reported to device makers, but the reporter may not know whether your device contributed to the event. Determining the root cause of an adverse event requires investigation. If the medical device was not part of the root cause this can be shown through the investigation records. Having said that, I would advise most companies to be very conservative in such determinations. Of course, you don’t need to report if after an investigation you discover the reported event was erroneous, didn’t actually occur, or your company is not the manufacturer. Additionally, there can often be multiple reporters of the same event. For example, If a doctor calls, as well as the patient, the device manufacturer only needs to report the event one time. However, you should always bear in mind that additional information, gained from separate reporters of the same event, might necessitate a follow-up report.
Clarification on follow-ups
There is one confusing portion of the guidance document that we hope is an oversight and that FDA will correct in a new edition. We’ve reached out to FDA for clarification. When companies find it necessary to submit a supplemental report, they might have to complete 50-75 different fields to complete via XML. Follow-up reports should only contain the fields that are different from the original report. If you’ve just learned two pieces of new information, you’re supposed to submit only those two pieces of information on top of the report ID. But this is rather cumbersome from a technical standpoint with the electronic file. In reality, it is easier to submit the entire document again.
In 2015, when FDA went live with the latest system for making electronic reports mandatory, the agency said it had fixed an issue with their old adverse event database whereby manufacturers could resubmit the entire package. The system is able to determine and update only the aspects of the submission that need to be updated.
The new version of the adverse event database still contains instructions specifying the original process of submitting only the new or changed data. So, manufacturers are somewhat confused over what FDA wants. It could be that policy makers kept the old language, not realizing that the technical side had already resolved the issue.
The take home
This final guidance on medical device reporting document answers a great number of questions, and facilitates decision-making so that manufacturers don’t have to continually turn to FDA and ask questions. In today’s regulatory environment, companies don’t have time to wait for an e-mail or phone call response from FDA. It’s always better to do this adverse event stuff right the first time! Nobody wants to have to constantly resubmit data to get it right.
Managing an adverse event can be a very stressful time for an organization. FDA has published a very useful tool for manufacturers to have on hand. FDA is always willing to hear more questions from industry and can always make more revisions to this should more questions come up.
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