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Government Watchdog Recommends FDA Improve Cybersecurity Reviews

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.

Security concept: Lock on digital screen, contrast, 3d render

A new report published by the government watchdog office overseeing US FDA says the agency needs to make some updates to how it evaluates medical device cybersecurity during its pre-market review process. The report comes as FDA is already in the middle of updating its pre-market cybersecurity guidance.

The Office of Inspector General at the US Department of Health and Human Services released a report Sept. 11 recommending steps FDA should take to oversee cybersecurity of medical devices....

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