FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions¶

Guidance for Industry and Food and Drug Administration Staff¶

This guidance is addressed to medical device manufacturers in the framework of premarket submissions, even though the FDA recognizes that medical device security is a shared responsibility among all the stakeholders: healthcare facilities, patients, healthcare providers and manufacturers.

This guideline presents at the beginning the main principles to improve the cybersecurity of a medical device by establishing a quality system through design controls. It recommends a series of security objectives to meet during the design process and encourages manufacturers to have a secure product development framework to meet the quality system regulations requirements. It also stresses the importance of transparency via providing labelling and documentation so device users can have access to information relevant to the cybersecurity of the device. The FDA explains in more detail why a secure product development framework is useful in terms of cybersecurity and compares it with other frameworks and international standards. This framework brings up security risk management, security architecture and cybersecurity testing to be addressed. Finally, the document refers to cybersecurity transparency through labelling recommendations and vulnerability management plans. The FDA also gives detailed descriptions of security control categories together with recommendations on how to address them.

\"This document provides FDA's recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This document supersedes the final guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued October 2, 2014.\" - FDA gov

The guidance document is publicly available here: FDA Guidance