Medical Device Reporting: Submitting Reportable Events Identified in Literature
Aspiring Towards a Streamlined Approach to Reporting MDRs
The Medical Device Innovation Consortium (MDIC) Medical Device Reporting (MDR) working group collaborated with industry and the U.S. Food & Drug Administration (FDA) to identify ways to improve the MDR process for product complaints found in scientific literature. In 2016, the FDA published guidance on MDR reporting, which includes information specific to MDRs for events from literature. Through a comprehensive review of the guidance, data collection and benchmarking, the MDIC MDR working group has identified that Industry has an inconsistent approach to reporting MDRs originating from literature. This proposed clarification is intended to address the industry’s inconsistent interpretation of the FDA’s MDR literature guidance, and subsequently the current approach in reporting MDRs for events from literature sources using the FDA form 3500A.
This report provides insight on how to interpret the existing FDA guidance on MDRs for events from scientific literature, specifically, when an individual MDR should be submitted versus when multiple reportable events may be submitted on one MDR. For example, when an individual MDR is expected, minimum patient and device information is identified for consideration as “specific information about some or all of the reportable events” that enables a manufacturer to “provide a complete report for each reportable event” in an individual MDR. Within this paper are common situations from scientific literature, which are not believed to provide enough necessary information to submit a complete MDR, and therefore when it would be appropriate to submit one (1) MDR with multiple reportable events of the same reportable event type.
Based on this collaborative effort, MDIC recommends to FDA and industry that a streamlined approach to reporting MDRs from literature, as proposed herein, results in greater efficiencies for industry and the agency, while leading to more transparent and accurate MAUDE data for patients and healthcare professionals.