Background A late-stage medical device manufacturer faced a major regulatory setback after the FDA questioned their premarket cybersecurity submission. Their Software Bill of Materials (SBOM) listed nearly 100 unfixed vulnerabilities spanning embedded firmware, cloud...
Preparing for CVSSv4: Why Medical Device Manufacturers Must Act Now
Summary
The FDA currently accepts CVSSv3 for rating vulnerabilities under its 2025 Premarket and 2016 Postmarket Cybersecurity Guidance, but will phase out support by 2027 in favor of CVSSv4 a newer, more complex standard that is not backward-compatible. CVSSv4 introduces parameters like Attack Requirements and Subsequent System Impact, which require a full-system view of how vulnerabilities interact and what happens if a component is compromised. This makes manual scoring impractical at scale. ELTON automates these determinations by modeling the system architecture and attack paths, enabling manufacturers to meet FDA expectations for CVSSv4 without adding staff or sacrificing traceability.
The FDA has officially recognized CVSS v4.0 as a consensus standard for medical devices, marking a significant shift in how cybersecurity risk will be assessed across both premarket and postmarket activities. While CVSS v3.1 remains acceptable under the current 2025 Premarket Cybersecurity Guidance and the longstanding 2016 Postmarket Management of Cybersecurity in Medical Devices guidance, that window is closing. By 2027, the FDA intends to phase out support for CVSSv3, forcing manufacturers to adopt CVSSv4 for vulnerability rating and risk assessment.
This transition is more than a procedural update—it introduces a non-trivial technical challenge for device manufacturers, particularly those with large, complex, or legacy product lines. CVSSv4 is not backward-compatible with CVSSv3, and existing CVSSv3 scores cannot be upscaled or translated. Attempting to re-score past or ongoing vulnerabilities using CVSSv4 will require complete re-analysis—something that is nearly impossible to do manually at scale or accurately.
Why CVSSv4 Is More Demanding
CVSSv4 introduces new parameters, such as:
-
Attack Requirements (AT): Which measure the conditions under which an attack can succeed, requiring insight into whether other vulnerabilities or system states must exist for exploitation.
-
Subsequent System Impact: A new vector that captures the ripple effect of a successful attack, specifically, what assets can be accessed or affected after a vulnerable component is compromised.
These concepts demand a complete system-level view. You must understand not just the vulnerability itself, but how that vulnerability exists in context: its role within data flows, its surrounding trust boundaries, and how it interrelates with other weaknesses or protections across the product.
This type of analysis is unmanageable using spreadsheets or traditional ticket-based triage models.
ELTON Automates What CVSSv4 Requires
ELTON was built specifically to address the limitations of CVSSv3 scoring and to support the more sophisticated scoring required by CVSSv4. The platform generates a machine-readable digital twin of each product and uses that model to automate:
-
Attack Requirements (AT): ELTON understands the presence of other vulnerabilities and how they relate within a potential attack path. It automatically evaluates whether a specific vulnerability becomes exploitable only when chained with others in the system.
-
Subsequent System Impact: ELTON tracks trust boundaries and component access, allowing it to calculate the downstream effects of an exploited vulnerability. For example, if an update daemon is compromised, ELTON can model how its permissions or network access could be used to breach otherwise isolated subsystems.
This level of visibility and automation allows manufacturers to move to CVSSv4 without doubling staff or reworking processes. It also ensures that scoring is consistent, traceable, and aligned with FDA expectations, across both premarket submissions and ongoing postmarket maintenance.
The Clock Is Ticking
Manufacturers relying on CVSSv3 will face mounting regulatory pressure between now and 2027. Delaying CVSSv4 adoption risks falling out of compliance, introducing avoidable remediation costs, and weakening defensibility during audits.
With ELTON, the shift to CVSSv4 is not only feasible it becomes a competitive advantage. ELTON allows teams to make better, faster vulnerability decisions across complex systems, with built-in support for CVSSv4 logic and an FDA-recognized methodology.
Now is the time to modernize your vulnerability process.
For more on the FDA’s recognition of CVSSv4, see the FDA’s official standards database.
