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FDA Proposal For Cybersecurity Info In Pre-market Submissions Generates Debate

Medical device firms and internet security groups disagree over whether an FDA guidance should recommend that companies document their cybersecurity measures in pre-market submissions.

Medical device manufacturers and internet security groups butted heads in comments on FDA’s June draft guidance on cybersecurity in medical devices. Some device firms asked FDA to remove its recommendations for cybersecurity documentation in pre-market submissions, while security groups said FDA should go further to require cybersecurity documentation for all devices.

Public comments were due in September on FDA’s June draft guidance, “Content of Pre-market Submissions for Management of...

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