Drug/Software Combo Pathway Coming Soon To US FDA, Gottlieb Says
Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.
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Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.
After industry stakeholders raised concerns that Apple may have received preferential treatment when US FDA approved heart-rhythm apps on the Apple Watch Series 4, Commissioner Scott Gottlieb states in a blog post that the agency's approach was in accordance with its standard procedures and reflect the benefit of early interaction with FDA.
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.