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Keys To FDA Advisory Panel Prep For Device Makers

Law360 (May 15, 2018, 2:32 PM EDT) -- Receiving U.S. Food and Drug Administration clearance or approval is critical for any medical device company looking to bring new products to market. A handful of premarket approval applications, as well as some de novo reclassifications, must brave the advisory panel process each year. Panel meetings — which result in a recommendation to the FDA that can ultimately “make or break” a product — mean consolidating and presenting years and years of product development and clinical findings, which can be a difficult undertaking for companies who...
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