FDA Calls for 'Cybersecurity Bill of Materials' for Devices

October 19, 2018 Mayuri Kumar

Before marketing their medical devices, manufacturers should prepare a "cybersecurity bill of materials" that lists components that could be susceptible to vulnerabilities, according to a draft of updated Food and Drug Administration premarket guidance.

In addition to releasing the proposed guidance this week, the FDA announced a formalized agreement with the Department of Homeland Security to implement a new framework for greater collaboration between the two agencies for addressing cybersecurity in medical devices.

Mac McMillan's comments are featured in this article.

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