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  "authorName": "Carson C. Block",
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      "text": "Should STJ not voluntarily recall these Devices once informed of the high probability that the device would cause serious, adverse health consequences or death, the FDA has ample regulatory basis to order a recall.",
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      "text": "The Draft Guidance focuses on “assessing the risk to the device’s essential clinical performance”. Essential clinical performance is the “performance necessary to achieve freedom from unacceptable risk”.",
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      "text": "The FDA issued a draft guidance document entitled “Postmarket Management of Cybersecurity in Medical Devices” (the “Draft Guidance”) on January 22, 2016. The Draft Guidance details FDA’s current thinking on “managing postmarket cybersecurity vulnerabilities for marketed medical devices.”",
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