FDA Will Update Cybersecurity Guidance For Medical Devices

By Emily Field (October 1, 2018, 5:56 PM EDT) -- The U.S. Food and Drug Administration said Monday that it's going to significantly update cybersecurity guidance for medical devices, warning the threat of cyberattacks is no longer theoretical.

The FDA said that in the coming weeks, it's going to publish an overhaul to the guidance it finalized in 2014 on how medical device manufacturers should build safety controls to protect against data breaches and viruses. The new draft guidance will highlight the importance of providing customers and users with a "cybersecurity bill of materials," or in other words, a list of commercial and off-the-shelf software and hardware components of a device...

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