FDA issues final version of long awaited cybersecurity guidance

FDA issues final version of long awaited cybersecurity guidance

The long-awaited guidance will help resolve past
uncertainties about expectations of cybersecurity
in the pre-market review of medical devices.

Today, FDA issued its long-awaited cybersecurity guidance for pre-market review of medical devices.  This is a document years in the making.

A PDF of the actual guidance document appears here.

A second draft cybersecurity guidance document on post-market practices (e.g., vulnerability and incident reporting) is expected later this year.

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