FDA's 510(k) pathway is getting stronger, medtech attorney says

06/5/2013 | MassDevice.com (Boston)

While the FDA's 510(k) program could be improved, it remains a robust framework for reviewing less-risky devices, medtech attorney Jeffrey Shapiro wrote in an analysis. While Shapiro believes the program could be improved with greater transparency, among other fixes, he does not agree with the Institute of Medicine's 2011 report recommending that the program be scrapped. "[T]he 510(k) program has proven adaptable to a wide variety of devices, and has allowed meaningful premarket review while fostering robust technological innovation," he wrote.

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