FDA Starts New Office of Digital Transformation, Affecting Devices

September 17, 2021

The FDA is reorganizing its information technology, data management and cybersecurity functions into a new Office of Digital Transformation in a move that will have implications for medical devices.

The new office’s cybersecurity function will be especially relevant to devices, given increasing concerns about the vulnerability of some devices to online hacking.

The agency has cautioned that medical device software can become vulnerable to cyber threats, “especially if the device is older and was not built with cybersecurity in mind.”

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