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    Perspectives on FDA Review of Medical Devices: Part 2

    The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews. Consider a Pre-Submission Meeting One particular strategy we have found quite productive, particularly for more-complex or innovative devices, is to...
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    Perspectives on FDA Review of Medical Devices: Part I

    In recent months, I have attended various medical conferences and trade shows that have highlighted many of the most promising med-tech innovations. From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. Yet, as a regulatory professional, I was struck by the numerous calls for the US Food and Drug Administration (FDA) reform and the claims FDA is st...