Device QS Cybersecurity Guidance

FDA has published a guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document represents the agency’s current thinking on the topic and says that for applications currently pending with FDA and those submitted after publication of the guidance, the agency intends to work collaboratively with manufacturers of such premarket submissions as part of its review process.

With the increasing integration of wireless, Internet- and network-connected capabilities, portable media, and the frequent electronic exchange of medical device-related health information and other information, FDA says, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important.

The guidance contains an Introduction, Scope, Background, General Principles, Using an SPDF (secure product development framework) to Manage Cybersecurity Risks, Cybersecurity Transparency, and five appendices.