FDAs New Cybersecurity Premarket Submission Guidelines

Download this guide to gain a better understanding of what's expected of Medical Device Manufacturers in submissions today, and where you need to focus your posture management resources moving forward.

What's included

• Review of the 4 Omnibus Bill submission requirements

• Deep-dive into the key pillars of the FDA’s newest requirements

• Related links for further reading for all relevant topics

• eSTAR documentation checklist

About Sternum

Sternum is an IoT security and observability platform. Embedded in the device itself, it provides deterministic security with runtime protection against known and unknown threats; complete observability that provides data about individual devices and the entire device fleet; and anomaly detection powered by AI to provide real-time operational intelligence.

Sternum operates at the bytecode level, making it universally compatible with any IoT device or operating system, including RTOS, Linux, OpenWrt, Zephyr, Micrium, and FreeRTOS. Plus, it has a low overhead of only 1-3%, even on legacy devices.