US FDA's Digital Health Plan Could Brighten OTC Device Outlook
This article was originally published in The Pink Sheet & The Rose Sheet
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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Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.
Many CHPA members also market medical devices "and the consumer side of medical devices is something they feel is underrepresented by other trade associations,” says trade group head Scott Melville. OTC drugs already have “a lot in common” with consumer medical devices, including that paying for neither typically is included in health insurance plans.