Guidance for unique device identifier labeling of convenience kits has been of particular interest to orthopedic manufacturers. FDA's new recommendations include several orthopedic examples of ways that combined products may or may not be considered convenience kits.
So far in 2019, funding has driven R&D and regulatory activity for companies working to get their first product on the market, as well as those seeking to expand globally. We look at nine companies with novel technologies that have boosted their capital through outside investments.
We're detailing the five winners of the National Capital Consortium for Pediatric Device Innovation's pitch competition who received a monetary prize in grant funding, as well as access to an accelerator program led by MedTech Innovator.
Learn more about each winner
This paper offers guidance on practical aspects of the large undertaking that is implementation, and highlights major regulation changes focusing on scope, new product development, quality management systems, postmarket surveillance, labeling and more.
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