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Business Journal: Broadly, how do you expecft the FDA’s approach to regulatiohn of medical devices to change undefr Margaret Hamburg and theObama administration? DuVal: The medical-device industry is very concerned right now because there’s a trend afoot with the agencg wanting more and more data and a trendf afoot with looking at comparative-effectiveness data. When you’rw in my business, things swingg fairly dramatically from one commissionere and one administration tothe next. Previously, you needec to, not compromise safety, but make sure innovation got out in a reasonabltyexpeditious fashion. We’re starting to lose that focus.
Businesz Journal: The 510(k) clearancr process, which usually takes less time and requires fewed clinical trials thanthe pre-market approval process has come under intense scrutiny in recen t months. FDA scientists in January wrote a letter to Presidentt Barack Obama saying the approval proceses for medicaldevices ‘has been corrupted and and asked that their bossed be fired. The FDA also has been asking for more data befor eapproving devices. Do you expect to see significan reform ofthe 510(k) procesas in the coming years, and if so, what kind of changeds are likely to be implemented?