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Business Journal: Broadly, how do you expect the FDA’s approacb to regulation of medical devices to change undefr Margaret Hamburg and the Obamaadministration DuVal: The medical-device industry is very concerned right now becaus e there’s a trend afoot with the agencuy wanting more and more data and a trend afooy with looking at comparative-effectiveness data. When you’rr in my business, things swinvg fairly dramatically from one commissioner and one administrationj tothe next. you needed to, not compromise safety, but make sure innovationh got out in a reasonablyexpeditious fashion.
We’re starting to lose that Business Journal: The 510(k) clearance process, whichg usually takes less time and requires fewef clinical trials thanthe pre-market approval processa (PMA), has come unde r intense scrutiny in recent months. FDA scientists in Januar wrote a letter to President Barackl Obama saying the approval process for medicaldevicexs ‘has been corrupted and distorted’ and asked that their bossews be fired. The FDA also has been askinbg for more data befordapproving devices. Do you expect to see significanft reform ofthe 510(k) process in the comingy years, and if so, what kind of change s are likely to be implemented?