From: Mass Device
BY
FDA Commissioner Scott Gottlieb today released a statement laying out the federal watchdog’s plans for improving medical device regulation, including plans to improve cybersecurity and monitor the total product life cycles of devices.
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The plan focuses on five key areas, including improving medical device cybersecurity, integrating premarket and postmarket activities to monitor the total product lifecycle of products, establishing a medical device patient safety net in the US, exploring regulatory options to “streamline and modernize” implementation of postmarket mitigations and promoting safer medical device innovation, according to the FDA release.
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