FDA’s Latest Post-Market Plan: Data-Mining Device Safety
This article was originally published in The Gray Sheet
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.
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The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.
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