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Proposed Changes to FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: What you Should Know

HL Chronicle of Data Protection

The new draft premarket cybersecurity guidance provides information designed to aid manufacturers in determining how to meet the agency’s expectations during premarket review of medical devices. This is the first time that FDA has been clear as to its expectation that it be created by manufacturers and provided to customers.

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NIST Holds a Two-Day Public Workshop on Cybersecurity Labeling Programs for Internet of Things Devices and Software

Hunton Privacy

In May 2021 , NIST released a draft white paper that summarized its review of the currently available confidence mechanisms for the security of consumer IoT devices and in August 2021 , NIST released a draft white paper that detailed draft baseline security criteria for consumer IoT devices.