A cybersecurity management plan describes how a manufacturer will find, fix and communicate vulnerabilities after release. For cyber devices, section 524B(b)(1) requires such a plan in the premarket submission. FDA's guidance lists nine elements, including named owners, monitoring sources, KEV handling, patch timelines and a coordinated disclosure process.
The legal hook
Section 524B(b)(1) requires "a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures." The guidance recommends cyber device makers use the management plan elements below for that plan. FDA recommends other manufacturers submit one as well, so it can judge how safety and effectiveness will be kept after authorization.
The nine elements
- Personnel responsible. Name roles, not just a team inbox.
- Sources, methods and frequency for monitoring. The guidance names researchers, the NIST National Vulnerability Database and third party software manufacturers as examples.
- Handling of CISA Known Exploited Vulnerabilities. Identify and address any that affect the device. See the KEV catalog explained.
- Periodic security testing.
- Timeline to develop and release patches.
- Update processes.
- Patching capability, meaning the rate at which an update can be delivered to devices.
- Coordinated vulnerability disclosure process.
- How forthcoming fixes and updates will be communicated to customers.
What coordinated disclosure covers
For 524B, the guidance says coordinated vulnerability disclosure could include disclosure of issues found by outside parties such as suppliers and researchers, disclosure of issues the manufacturer finds itself, and the procedures for carrying out those disclosures. Those procedures may include informing users, customers, patients and other healthcare parties.
Timelines need reasons
The guidance says plans should also describe the timeline, with justifications, for developing and releasing required updates and patches. It states the justification for a regular patch cycle should typically be in the management plan. It gives risk as a main factor in cycle length. A connected thermometer limited to taking temperature may justify a different cycle than a connected surgical robot, though a seemingly low risk device may offer a route to others in its environment.
Patching capability is a design property
Item 7 is where many plans fail. If a device can accept updates only through a technician visit, the plan's timelines must reflect that. The guidance asks manufacturers to plan for rapid testing and evaluation of patches, to keep build environments and test suites for the whole supported life, and to keep third party licenses current.
Keep it alive
A plan filed once and never opened does not meet its purpose. Review it when a component reaches end of support, when a KEV entry hits a dependency, or when the update path changes.
Teams that need an up to date component list to feed monitoring can use dependency scanning. Safeguard offers SBOM and dependency scanning, with a free scan at https://gold.safeguard.sh/scan. A scan supports the monitoring element and does not replace the plan.
Quick check
Is a vulnerability disclosure policy the same as the management plan?
No. Coordinated disclosure is one of the nine elements. The plan also covers monitoring, testing, patch timelines, update processes and customer communication.
Sources
Last reviewed: 19 October 2026.
