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HHS Agenda: Regulations To Watch For In 2013

This article was originally published in The Gray Sheet

Executive Summary

Regulations agenda includes a proposed rule to establish standardized symbols in medical device labeling, as well as plans to issue the unique device identification final rule.

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Regulatory News In Brief

Minnesota device makers petition FDA. Invacare lays off workers following FDA consent decree. More regulatory news.

Final UDI Rule Date Uncertain, But Firms Should Prep Now, FDA Says

FDA likely won’t meet a May 2013 statutory deadline to issue final regulations for unique device identifiers, but that does not mean companies should delay efforts to comply. And firms should not rely on expected exemptions to the UDI mandate, an agency official said.

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.

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