In medical device cybersecurity, the most expensive mistake is not missing a vulnerability. It is fixing the wrong one. Manufacturers are often pressured to remediate every reported CVE to avoid regulatory scrutiny, even when those vulnerabilities are not exploitable...
The Hidden Complexity of FDA Cybersecurity: Why Every Product Release Is Its Own Lifecycle
Summary
Medical device cybersecurity compliance under FDA expectations is far more complex than managing a single product. Each commercial release of every product has its own unique vulnerability profile, is affected by different CVEs over time, and must be supported with its own SBOM, vulnerability monitoring, and annual testing through end of life. Changes between releases, even minor ones, alter software composition and exposure, requiring regulators to evaluate cybersecurity at the release level rather than across an entire product line. As portfolios grow, this creates a compounding operational burden that is difficult to manage without structured systems. Treating each release as its own lifecycle is essential for maintaining traceability, audit readiness, and defensible cybersecurity decisions.
For medical device manufacturers, cybersecurity compliance is no longer scoped at the product level. Under modern FDA expectations, every commercial release of every product is treated as its own cybersecurity lifecycle. Each release has a unique vulnerability profile, is exposed to different CVEs over time, and must be supported with its own evidence, documentation, and testing. This requirement has introduced a level of operational complexity that many organizations underestimate until they are in the middle of an audit.
The FDA’s total product lifecycle approach makes one thing clear. A product is not a single static artifact. Each released version represents a distinct combination of software, firmware, configurations, third party components, and security controls. As a result, vulnerabilities that apply to one release may not apply to another, even within the same product family.
Why Vulnerability Profiles Differ by Release
Every release changes something. A library version is updated, a feature is added, a configuration is modified, or a dependency is removed. These changes directly affect which CVEs are applicable, which attack paths exist, and how exploitable a vulnerability may be. Two releases of the same product can have materially different risk profiles even if they appear functionally similar.
Because CVEs continue to emerge long after release, older versions may become exposed to issues that never affect newer versions. At the same time, newer releases may introduce vulnerabilities that do not exist in legacy products. From a regulatory perspective, this means vulnerabilities cannot be tracked generically across a product name. They must be tracked per release.
SBOMs Are Required Per Release, Not Per Product
FDA guidance has made it clear that a Software Bill of Materials reflects the software composition of a specific build. When software changes, the SBOM changes. That means each commercial release requires its own SBOM that accurately represents the components and versions included in that release.
This creates a compounding challenge. Manufacturers must not only generate SBOMs for each release, but also monitor them independently. A CVE affecting a third party component may impact one release and not another, depending on versions, mitigations, or exposure paths. Regulators expect manufacturers to demonstrate awareness of these differences and manage them accordingly.
Annual Testing Applies to Each Active Release
Cybersecurity testing is not a one time activity. FDA expectations around vulnerability management, penetration testing, and postmarket surveillance apply annually and per active commercial release. If a manufacturer has multiple supported releases in the field, each one must maintain its own cybersecurity posture through end of life.
This means penetration testing, vulnerability analysis, and risk evaluation must be organized and documented by release. During an FDA audit, reviewers assess a specific product version, not the entire product line. Mixing vulnerability data across releases makes it difficult to demonstrate control and traceability, and often leads to follow up questions or findings.
The Operational Burden Adds Up Quickly
As product portfolios grow, the effort required to manage cybersecurity scales non linearly. Multiple products, each with multiple active releases, quickly turn into dozens or hundreds of parallel cybersecurity lifecycles. Each one requires SBOM maintenance, vulnerability monitoring, annual testing, and documented justification for remediation decisions.
Without a structured system, teams often resort to spreadsheets, shared folders, and manual tracking. This approach is fragile, difficult to audit, and nearly impossible to sustain as regulatory expectations continue to evolve.
Turning Lifecycle Complexity Into a Defensible System
Platforms like ELTON exist specifically to address this challenge. By treating each release as its own traceable entity, manufacturers can maintain clear separation between vulnerability profiles, SBOMs, test results, and risk decisions. This structure aligns naturally with how the FDA evaluates cybersecurity during premarket reviews and postmarket audits.
The key takeaway is simple but often overlooked. FDA cybersecurity compliance is not about securing a product once. It is about continuously managing the cybersecurity posture of every released version for as long as it remains on the market. Manufacturers that recognize and design for this reality are far better positioned to scale, defend their decisions, and avoid costly regulatory surprises.
