The document covers:

🔹 Outlines the requirements for premarket submissions for cybersecurity medical devices. It helps ensure that cybersecurity risks are appropriately managed​​​.

🔹 Applies to medical devices with the capability to connect (wirelessly, wired, or via internet) to another device, network, or portable media. The guidance does not apply to the submissions that are exempt from this policy​​​.

🔹 The guidance, when finalized, will represent FDA's current thinking on Refuse to Accept Policy for cybersecurity devices and related systems in premarket submissions​​​.

🔹 Provides recommendations to manufacturers for cybersecurity device design, labeling, and documentation to be included in their premarket submission​​.

🔗 Original Document:  https://www.fda.gov/media/166614/download