Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
A-fib registry
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EU Parliament’s Public Health Committee Debates Device Reform Proposal
Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.
Eucomed Q&A: Where Do EU Regs Get It Right? An Emphasis On Innovation
With U.S. medical device regulatory reforms looming, comparisons between the U.S. and European systems have become popular talking points in the debate over where FDA should be heading.
Eucomed Q&A: Where Do EU Regs Get It Right? An Emphasis On Innovation
With U.S. medical device regulatory reforms looming, comparisons between the U.S. and European systems have become popular talking points in the debate over where FDA should be heading.