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FDA’s Latest Post-Market Plan: Data-Mining Device Safety … And Then There’s MAUDE

This article was originally published in The Silver Sheet

Executive Summary

Data-mining software tools will be used by FDA to find troubling patterns with particular devices as part of the agency’s latest plan to beef up its post-market surveillance activities. However, “we haven’t determined the device areas in which we will implement data-mining,” CDRH Chief Scientist William Maisel said. Meanwhile, a new system will be piloted to replace the MAUDE adverse event database, and CDRH Director Jeffrey Shuren explains why Unique Device Identification and product registries will play an important role in the new post-market plan.

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