Inside Cybersecurity

March 18, 2024

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FDA may seek authority to require medical devices be designed with cybersecurity

/ April 18, 2018

The Food and Drug Administration's medical device center may ask Congress for authority to require manufacturers to build cybersecurity into their product designs and, once a product is marketed, to disclose any vulnerabilities as they are identified.

The agency also envisions requiring device makers to include in their pre-market submissions a Software Bill of Materials that would be made available to customers and users so they can better manage networked assets and be aware of which devices may be vulnerable....


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