Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA tells small businesses how to qualify for discounted user fees. Agency plans September conference for industry on unique device identification proposed rule. More regulatory news.
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The long-anticipated proposal maps out a unique device identifier system that FDA says will be crucial to the future of post-market safety surveillance, recall management and safety alerts. The effort also will help reduce medical errors and bring an array of other benefits, stakeholders say.