US FDA readies to put fingerprints on mobile medical apps, reveals draft guidelines
This article was originally published in Scrip
Much has changed since 1989 when the US FDA prepared its first general policy statement on how it planned to regulate software-based medical products – with that first attempt going by the wayside after regulators decided it would be impractical to prepare an overarching software policy for the technology, which was increasingly growing more and more complex at a rapid pace.
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