By Heather Thompson, Medical Design & Outsourcing, Jan. 2017
Interview with 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.
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