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Regulation Cybersecurity Approvals

Government Watchdog Recommends FDA Improve Cybersecurity Reviews

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Executive Summary

HHS OIG is recommending US FDA hold more pre-submission meetings, amend their Refuse-to-Accept checklist and update their "Smart" template for agency reviewers to improve oversight of medical device cybersecurity.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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