FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices | King & Spalding

The FDA has finalized guidance on cybersecurity in medical devices, which replaces guidance issued in 2014. Encouraging a new “Secure Product Development Framework,” the guidance also emphasizes the importance of improved cybersecurity transparency. Included is advice for the application of AI and machine learning in medical device manufacture, and steps for dealing with cybersecurity risks. The document also provides an update on legislation regarding the requirement for “software bills of materials” in marketing applications.