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FDA Issues Draft to Update Prior Final Guidance on Premarket Cybersecurity For Medical Devices - E-Discovery, Information Governance & Cyber Security Section News

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E-Discovery, Information Governance & Cyber Security Section News


Posted on: Oct 24, 2018

From Barnes & Thornburg LLP:

The FDA recently issued a draft guidance document titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The draft guidance states that, when finalized, it will replace the final guidance issued in October 2014, with the same name. According to the FDA, “the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations, necessitates an updated approach.”

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