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US FDA's Digital Health Plan Could Brighten OTC Device Outlook

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

FDA says its "traditional approach" for hardware-based medical devices of moderate and higher risks "is not well suited for the faster iterative design, development and type of validation used for software-based medical technologies. Digital technologies such as mobile apps likely will have a role in facilitating additional Rx-to-OTC drug switches.

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