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Device-Makers Need To Open Up More On Cybersecurity In Pre-Market, Draft Guidance Says

Executive Summary

A new update to the pre-market cybersecurity guidance issued four years ago reflects how US FDA's thinking on the issue has evolved, as more cases of device vulnerabilities have surfaced. Among the key updates are recommendations for sponsors to submit a cybersecurity "bill of materials" in product labeling to better coordinate with end-users and to use a two-tiered risk management approach.

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