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Comments on 510(k) Draft Guidance

Because the 510(k) Program plays an important role in the regulation of mHealth technologies, the Coalition filed comments on the FDA’s draft guidance on April 26, 2012. Although the Agency’s draft guidance is a significant step toward clarifying the 510(k) Program, there are a number of areas that need clarification to produce a clear, predictable, and narrowly-tailored regulatory framework that promotes patient safety and innovation in mHealth.

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