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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Judge Orders FDA To Hand Over Whistleblower Surveillance Documents
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Sequestration Threat Looms For 2013 Health Care Spending
A report from Sen. Tom Harkin states that impending across-the-board cuts would lead to major NIH grants reduction, in addition to significant spending cuts for cancer and HIV screening.
FDA’s UDI Draft Rule Details Device Marking, Database Submission Mandates
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.