FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)

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All authors

April 7, 2023

FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)

With the release of the new FDA “cyber device” RTA guidance, it is now a requirement, enforceable on October 1, 2023, that medical device manufacturers (MDMs) have documentation of all the software components used to build their device, also known as a software bill of materials (SBOM). A “cyber device”, to which the RTA guidance applies, is one that includes software as a device or in a device, has the ability to connect to the internet, and contains technological characteristics that could be vulnerable to cybersecurity threats.

The SBOM is not just a list of components, but it is something that can be used with a software tool to automatically scan for vulnerabilities and versions. The output of this will enable manufacturers to identify impact and schedule software updates, including vulnerability patches, at appropriately identified timelines.

The goal of this guidance is to ensure that manufacturers improve the design, labeling and documentation for device premarket submissions. This newly enforced guidance may feel like yet another hurdle to getting your product to market, but failure to do so will be a basis for FDA to Refuse to Accept your submission — ultimately delaying the time-to-market for your device.

Follow along this week as we break down how the guidance affects your organization. Register for the free webinar on April 11 at 10:30am PT/1:30pm ET to learn more from MedCrypt’s experts.

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