September 12, 2018

FDA takes steps to address cybersecurity concerns of medical devices

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) has taken steps to ensure that medical device manufacturers do as much as possible to defend against hacking and other threats to their devices, according to a new report from the Department of Health & Human Services Office of Inspector General.

The FDA is making changes to its internal processes by reviewing cybersecurity information early on in submissions, and obtaining additional information from manufacturers when needed.

The FDA could take additional steps to further integrate cybersecurity more fully into its overall review process, the report says.


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