FDA finalises mobile medical applications guidance

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On 23 September 2013, the Food and Drug Administration (FDA) released the long-awaited mobile medical applications final guidance. Coming more than two years after its initial draft, the final guidance provides further clarity and insight into the FDA’s current thinking on the regulation of applications meant to run on a mobile platform or on a browser tailored for use on a mobile platform.

Following release of the earlier draft guidance, the FDA solicited public comment and reportedly received more than 130 such comments. According to the agency, the comments were largely supportive of the FDA’s general proposed approach. Consistent with that view, the final guidance proposes the same fundamental approach to regulation of mobile medical apps as was featured in the draft guidance…

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