Why FDA's New Cyber Device Regs Are a 'Watershed Moment'
Kevin Fu of Northeastern University on How the Regulations Will Ensure Uniformity
April 18, 2023
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About this episode
The FDA's new cybersecurity policy is a "watershed moment" for the industry, says Kevin Fu of Northeastern University. The agency will soon begin rejecting manufacturers' new medical device submissions that lack detailed cybersecurity measures, which will help ensure uniformity, he says.