Postmarket Penetration Testing is Standard for Medical Device Cybersecurity Compliance

For medical device manufacturers, cybersecurity is no longer a one-time activity—it is a regulated, continuous obligation. One of the clearest expectations emerging across FDA guidance and global regulations is periodic penetration testing, typically performed annually. While not always written as a hard requirement, annual testing has become a practical necessity to maintain compliance and withstand audits.

FDA Guidance on Periodic Testing

The FDA’s 2016 Postmarket Cybersecurity Guidance (soon to be updated in 2025) sets the tone:

“Cybersecurity testing should be performed at regular intervals commensurate with the risk (e.g., annually)…”

This statement has driven many manufacturers to adopt annual penetration testing as part of their quality system SOPs. It ensures they can demonstrate that vulnerabilities are being actively evaluated and that security controls remain effective.

The FDA’s 2023 Premarket Guidance further reinforces this approach. It emphasizes ongoing risk management throughout the product lifecycle and requires manufacturers to provide vulnerability management metrics in submissions. Penetration testing is one of the few methods that can validate whether SBOM-listed vulnerabilities are truly exploitable in the context of a specific device.

Global Regulators Moving in the Same Direction

While the FDA is the most explicit in recommending annual testing, other regulators and standards bodies around the world encourage the same practice:

• European Union (MDR/IVDR and MDCG guidance): Requires manufacturers to plan ongoing verification and validation of cybersecurity controls. Periodic penetration testing, often annual, is widely accepted as best practice to demonstrate compliance.

• Australia (TGA): TGA guidance highlights penetration testing as a core technical activity during development and postmarket. Manufacturers are expected to maintain regular testing schedules—annual for connected devices is common.

• Health Canada: Expects manufacturers to perform penetration testing during development and to continue it postmarket as part of vulnerability management SOPs. Annual cadence is considered the benchmark for demonstrating effective oversight.

• IMDRF (global consensus): Recommends periodic security testing, explicitly citing penetration testing as a best practice across the product lifecycle. Industry adoption generally translates “periodic” into annual to align with global norms.

• Singapore (HSA): Requires manufacturers to plan for ongoing penetration testing as part of their surveillance strategy. Annual testing is encouraged as a practical way to meet those expectations.

• Japan (PMDA / JIS T 81001-5-1): Embeds cybersecurity into lifecycle processes in alignment with IEC 81001-5-1. While not prescribing a frequency, manufacturers typically conduct annual penetration tests to demonstrate compliance.

• Saudi Arabia (SFDA): Requires vulnerability testing and validation throughout the device lifecycle. Annual penetration testing has become the accepted approach for satisfying these obligations.

Across regions, regulators converge on the same expectation: periodic penetration testing is required, and annual cadence is the most defensible standard.

Industry Practice and Audit Reality

In practice, about 75% of manufacturers conduct annual penetration testing, especially for connected or network-enabled devices. This practice is not just about risk reduction—it is about audit readiness. In multiple FDA inspections, findings have been issued when devices lacked recent penetration testing, even when vulnerability monitoring was in place. Annual testing provides manufacturers with evidence that risk assessments are grounded in real exploitability, not just CVE feeds.

Postmarket Value of Penetration Testing

Annual testing plays a particularly important role postmarket. It validates whether CVEs identified through SBOM monitoring are exploitable within the device architecture, helping manufacturers focus remediation efforts only on issues that matter. This prevents unnecessary patches that can introduce risk, add cost, or disrupt operations.

A Practical Compliance Strategy

While not strictly mandated in every case, annual penetration testing has become the accepted standard to align with FDA expectations, global frameworks like IEC 81001-5-1, and quality system best practices. It closes the gap between theoretical vulnerabilities and real-world risk, provides defensible evidence in regulatory submissions, and ensures ongoing product security.

For manufacturers, committing to annual testing is a cost-effective way to avoid audit findings, strengthen product safety, and build regulator and customer trust. With FDA guidance evolving in 2025 to increase postmarket accountability, this practice will only grow in importance.

How ELTON Uses Penetration Testing

ELTON incorporates penetration testing into postmarket operations as one of several vulnerability data sources. It serves as ground truth for identifying exploitable pathways and validating the effectiveness of security controls. These results enhance ELTON’s automated disposition of vulnerabilities, filtering noise from less intelligent sources such as SAST, DAST, or raw SBOM CVEs that lack clear exploitability context. By combining real-world testing with automated monitoring, ELTON improves accuracy, reduces unnecessary remediation, and provides manufacturers with defensible, regulator-ready outputs grounded in truth data.