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

 
• By Eileen Francis

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.

An FDA initiative to overhaul its approach to evaluating medical device proposals and ensure consumers have access to safe and effective products in the rapidly expanding digital health space could help provide momentum for developing mobile apps needed to make more drug ingredients available OTC.

FDA must lean forward and adapt our processes” to provide consumers access to "the full potential of digital health technologies,"...

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