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FDA gets granular with draft medical device premarket approval update

The US Food and Drug Administration (FDA) has updated its premarket cybersecurity guidance to include devices that can connect to the internet. The draft guidance considers not only devices that are purposefully internet-enabled but potentially any device that could accidentally connect. The FDA also advised that device manufacturers prepare for potential vulnerability disclosures, adjust their plans as required and ensure robust threat modelling documentation.

Source: www.healthcareitnews.com –

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