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March 01, 2009 (Vol. 29, No. 5)

Making the Most of Pre-IDE Meetings

With Proper Use these Get-Togethers Can Be Valuable Assets for IVD Companies

  • In order to sell diagnostic devices in the U.S., in vitro diagnostic (IVD) manufacturers need to get marketing authorization from FDA. That raises an obvious question: How does a company know what data to submit and which regulatory pathway to use? One way is to ask FDA for ...

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