Cybersecurity threats and vulnerabilities in todays modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations, said FDA Commissioner Scott Gottlieb, M.D. The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this way, we can help ensure the health care sector is well positioned to proactively respond when cyber vulnerabilities are identified in products that we regulate. Todays draft premarket cybersecurity guidance provides updated recommendations for device manufacturers on how they can better protect their products against different types of cybersecurity risks, from ransomware to a catastrophic attack on a health system. Weve been implementing this guidance since it was finalized in 2014. Now, because of the rapidly evolving nature of cyber threats, were updating our guidance to make sure it reflects the current threat landscape so that manufacturers can be in the best position to proactively address cybersecurity concerns when they are designing and developing their devices. This is part of the total product lifecycle approach to device safety, in which manufacturers must adequately address device cybersecurity from the design phase through the devices time on the market to help ensure patients are protected from cybersecurity threats.

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