US FDA Commish Defends Approach To Apple Approvals
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.
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De novo summary documents published by the US FDA sheds more light on the agency’s work approving two de novos for Apple Watches last year. At the time, the approvals sparked concern from industry stakeholders on whether the company received preferential treatment. Former FDA Commissioner Scott Gottlieb pushed back against the notion in a lengthy blog post late last year.
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