Assessing Regulatory Responsibility When Reporting Postmarket Cybersecurity “Corrections” to the FDA

Whether you are a technology company venturing into FDA-regulated territory for the first time, or a longstanding member of the FDA-regulated medical device community, recent regulatory developments around cybersecurity may require a shift in your perspective in order to meet FDA expectations. In this guest article, DLA Piper attorneys analyze the FDA’s Postmarket Management of Cybersecurity in Medical Devices guidance, including important definitions, and advise on what postmarket cybersecurity-related product changes may or may not be reportable to the agency. See also “Securing Connected Medical Devices to Ensure Regulatory Compliance and Customer Safety (Part One of Two)” (Mar. 30, 2016); Part Two (Apr. 13, 2016).

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