Question 1

Do legacy devices need to comply with Section 524B?

Accepted Answer

Not directly, in most cases. Section 524B applies to cyber device submissions made after March 29, 2023, so a device cleared before then is not automatically subject to it. But that is not a free pass. Fielded devices remain covered by the FDA's postmarket cybersecurity guidance, quality system requirements, complaint handling, and correction and removal reporting, and any new submission for a modified version brings Section 524B in. In practice we help you document the device's current cybersecurity posture, reconstruct an SBOM from the deployed firmware where the original is missing, and run a coordinated vulnerability disclosure process, so you are ready either way.

Question 2

What's the difference between compensating controls and a full security update?

Accepted Answer

Compensating controls address risk within the device's current state - network segmentation, monitoring, access controls, hardened deployment configurations - without changing the cleared design or triggering a new submission. A security update changes the software, which usually requires verification, validation, and design history file updates, and may require FDA notification depending on the change. Compensating controls are the right tool when the device cannot be updated quickly, when the vendor has no current update path, or when a patch is in development but the risk needs to be reduced now.

Question 3

Can you help with a device that has no vendor support left?

Accepted Answer

Yes - this is exactly the scenario the service is designed for. When the original vendor is no longer supporting the device, Blue Goat Cyber provides the ongoing risk management the manufacturer can no longer provide: SBOM reconstruction from the deployed firmware, current-state threat modeling, compensating control design, and an inspectable postmarket cybersecurity record. For hospital systems running orphaned devices, we deliver the same package scoped to the deployment environment rather than the design.

Question 4

How does this service interact with our postmarket cybersecurity obligations?

Accepted Answer

Treat legacy device services as the practical implementation of your postmarket cybersecurity obligations for fielded devices, and as preparation for Section 524B if a modified version is ever submitted. The risk assessment becomes your current-state evidence; compensating controls become your documented mitigations; the engagement record becomes your audit trail. For manufacturers who also run an active CVD and SBOM monitoring program, the legacy work feeds directly into that pipeline - our FDA Postmarket Cybersecurity service provides the ongoing monitoring layer that sits on top of legacy remediation.

Question 5

Will compensating controls require us to file a new 510(k) or PMA supplement?

Accepted Answer

Almost never. Compensating controls live outside the device's cleared design - they're applied at the network, deployment, or operational layer rather than in the device software itself. That keeps the change outside the scope that triggers a new submission under 21 CFR 807.81(a)(3) or PMA supplement requirements. Where a borderline case exists (e.g. a configuration change that touches device-side settings), we document the change-control rationale so your regulatory team has a defensible position if the question is ever raised.

Question 6

Who is this service for - manufacturers or hospitals?

Accepted Answer

Both, with different scopes. For manufacturers, we work on devices you've cleared and are still responsible for - building the postmarket cybersecurity record, designing compensating controls, and maintaining an SBOM the FDA can inspect. For hospital and health-system security teams, we work across a multi-vendor fleet - assessing legacy devices in the deployment environment, designing segmentation and monitoring patterns, and producing documentation that satisfies HDO procurement and accreditation requirements. The deliverables differ; the underlying risk reduction approach is the same.

Question 7

Can you reconstruct an SBOM if the original software bill is missing?

Accepted Answer

Yes - SBOM reconstruction from deployed firmware is one of the most common requests on legacy work. We extract firmware images from a representative production unit (or a service replacement), unpack the file system, identify components by hash matching against public databases, decompile or signature-match where hashes don't resolve, and produce a CycloneDX or SPDX SBOM with provenance notes for every entry. The reconstructed SBOM then feeds the vulnerability matching, the postmarket monitoring program, and any FDA inspection request. We document the methodology so reviewers can see how the SBOM was derived and what's known versus inferred.

Question 8

How does this service support an end-of-support or end-of-life decision?

Accepted Answer

The FDA expects manufacturers to define and communicate end-of-support timelines and to provide reasonable cybersecurity support across a device's commercial life. We help you define a defensible EOL/EOS plan: criteria that trigger end-of-support (component obsolescence, OS unsupportability, hardware unavailability, accumulated vulnerability burden), the communication path to customers and HDOs, the technical wind-down plan for cloud-side services, and the documentation that goes into MAUDE, recall notices, or customer letters. Doing this proactively is much less expensive than doing it under FDA pressure after a CVD event.

Question 9

How do we hand off compensating controls to hospital deployment teams?

Accepted Answer

Compensating controls only work if the hospitals operating the device actually implement them. We produce a deployment-ready package: a one-page security implementation guide for HDO biomed and IT teams, a network architecture diagram showing the required segmentation, recommended firewall and ACL rules, monitoring and logging requirements, and a customer-facing FAQ that anticipates the questions HDO security teams will ask. For high-priority customers, we'll join a deployment call to walk their team through the controls. The customer-facing materials also serve as evidence in your postmarket cybersecurity record.

Question 10

What's the relationship between this work, MAUDE reporting, and coordinated vulnerability disclosure?

Accepted Answer

Vulnerabilities discovered during legacy assessment may need to flow into multiple downstream processes: an internal CVD triage to decide on disclosure, a CISA/ICS-CERT advisory if disclosure is appropriate, MAUDE reporting if patient harm occurred or could plausibly occur, customer notifications, and FDA recall consideration in serious cases. We map every finding through this decision tree at the time it's identified - including the safety-risk re-evaluation against your ISO 14971 file - so the regulatory team has clear options and timelines. The decision tree itself becomes part of your inspectable postmarket cybersecurity record.

Legacy Medical Device CybersecurityCompensating Controls & Risk Reduction for Fielded Devices.

How do you secure legacy medical devices already in the field?

What an unprotected legacy device costs you

Regulatory exposure

Patient safety drift

Commercial fallout

Legacy / installed-base attack surface

Reviewer-ready deliverables in one engagement

Public postmarket cybersecurity history

Urgent/11 IPnet stack vulnerabilities (ICSMA-19-274-01)

BD Alaris legacy infusion advisories

Try the free tool first.

Legacy / End-of-Support Triage

SBOM Readiness

Threat Model Starter

Legacy Device Protection - scoped, fixed-fee, FDA-ready.

Legacy device cybersecurity FAQs