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...
Postmarket Penetration Testing: Why Every Release Needs Its Own
Summary
Every commercial release of a medical device must be tested and monitored independently to meet FDA and global cybersecurity expectations. Vulnerabilities are specific to each release and cannot be mixed across versions, as audits and submissions are evaluated per release, not for the entire product line. The FDA’s guidance, along with international regulators, has made annual, release-specific penetration testing the defensible standard for demonstrating ongoing vulnerability management. ELTON simplifies this process by cataloging and tracking all vulnerabilities, SBOM data, and test results per release—ensuring only active, non-EOL versions are monitored annually and providing manufacturers with clean, regulator-ready evidence for every commercial release.
Why Every Release Needs Its Own Annual Penetration Test
For medical device manufacturers, cybersecurity is no longer a one-time activity; it is a regulated, continuous obligation tied to each commercial release of a product. FDA and other global regulators require that vulnerabilities be tracked and managed according to the specific release they belong to, not blended across versions.
Every commercial release represents a unique combination of software, firmware, and third-party components. Because vulnerabilities change with each release, the testing and evidence that apply to one version cannot automatically carry forward to the next. To maintain compliance, each active commercial release must undergo independent evaluation, typically through annual penetration testing, to confirm that vulnerabilities relevant to that release are identified, evaluated, and controlled.
Once a product or release reaches End of Life (EOL), it no longer requires annual testing or monitoring. However, all commercial versions that remain on the market must maintain active cybersecurity surveillance to meet regulatory expectations and defend against audit findings.
FDA Guidance on Periodic and Per-Release Testing
The FDA’s 2016 Postmarket Cybersecurity Guidance (soon to be superseded in 2025) sets the tone:
“Cybersecurity testing should be performed at regular intervals commensurate with the risk (e.g., annually)…”
This statement, though brief, has significant implications. Testing must reflect the current commercial state of the product, not a prior build or legacy release. The FDA audits specific releases, not entire product families. Therefore, vulnerability evidence must align with the commercial version under review.
Manufacturers that aggregate vulnerabilities across releases risk compliance issues because findings from one version may not apply to another. ELTON simplifies this challenge by cataloging all vulnerability data by release, automatically mapping each vulnerability, test result, and mitigation to the exact version it affects.
The FDA’s 2023 Premarket Cybersecurity Guidance reinforces this principle through its focus on ongoing risk management and vulnerability metrics within submissions. Penetration testing remains one of the few defensible ways to verify whether SBOM-listed vulnerabilities are truly exploitable in the context of a specific release.
Global Regulators Aligning on Annual, Release-Specific Testing
While the FDA provides the most explicit language, global regulators follow similar expectations:
European Union (MDR/IVDR, MDCG guidance): Requires periodic verification and validation of cybersecurity controls for each distributed version. Annual testing is accepted as best practice.
Australia (TGA): Expects annual testing for networked devices as part of continuous postmarket assurance.
Health Canada: Encourages recurring penetration testing on the released configuration, aligning with vulnerability management SOPs.
IMDRF: Recommends periodic security testing; industry practice interprets this as annual, per active release.
Singapore (HSA): Supports ongoing penetration testing tied to product release cycles.
Japan (PMDA / JIS T 81001-5-1): Embeds cybersecurity into lifecycle processes; annual testing by release is the practical compliance approach.
Saudi Arabia (SFDA): Mandates vulnerability testing and validation across the product lifecycle, typically annual and per active release.
Across jurisdictions, regulators converge on the same expectation: each commercial release must undergo periodic (usually annual) testing to confirm that vulnerabilities remain managed and traceable.
Industry Practice and Audit Reality
In practice, about 75% of manufacturers conduct annual penetration testing per release, especially for connected devices. This is driven as much by audit readiness as by risk management. FDA inspectors have issued findings when a tested configuration did not match the audited release or when vulnerabilities were not tracked per version.
Annual, release-specific testing provides a defensible record that each marketed version has been independently evaluated for exploitability. It eliminates ambiguity, ensures clear lineage of evidence, and provides traceable proof of continuous monitoring for the versions still in commercial distribution.
Postmarket Value of Penetration Testing
Annual testing helps manufacturers validate whether vulnerabilities identified through SBOM monitoring are exploitable within a given release’s architecture. This allows them to prioritize only issues that matter, preventing unnecessary patches, preserving device stability, and maintaining compliance without excessive cost.
ELTON enhances this process by organizing vulnerability data by release, ensuring that the right evidence supports the right version during regulatory inspections or audits. Each penetration test, CVE analysis, and disposition is stored and referenced against the correct release lineage, maintaining clean separation between versions.
A Practical Compliance Strategy
While annual penetration testing may not always be an explicit “shall” in every framework, it has become the accepted global standard to meet FDA, IEC 81001-5-1, and IMDRF expectations. Conducting annual, per-release testing closes the compliance gap between theoretical and real-world vulnerabilities and ensures that regulatory submissions contain defensible, version-specific evidence.
For manufacturers, this strategy provides:
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Reduced audit findings due to misaligned test evidence
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Clear traceability of vulnerabilities to the correct release
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Regulatory confidence in ongoing cybersecurity control
How ELTON Simplifies Per-Release Cybersecurity
ELTON is purpose-built to manage this complexity. The platform catalogs every vulnerability, penetration test, and SBOM entry by release, ensuring that each active version has a distinct compliance record. Only commercial, non-EOL releases are tracked and monitored annually, reducing unnecessary testing while meeting FDA expectations.
ELTON integrates penetration testing as ground truth alongside automated SBOM and vulnerability feeds, validating exploitability and control effectiveness. Its intelligence filters noise from raw CVE data, automatically producing regulator-ready outputs for each release.
By transforming fragmented cybersecurity testing into structured, release-specific intelligence, ELTON helps manufacturers stay compliant, audit-ready, and efficient—one commercial release at a time.
