FDA started mandating Software Bill of Materials (SBOM)

November 11,2025

   

In modern medical device development the software supply chain has become a mission-critical element. The FDA isn’t asking for your source code, they’re asking if you understand what’s in it. This subtle but profound shift matters. As of October 2025 (or more precisely the timeframe when the guidance became fully applicable) SBOMs are now required in pre-market submissions for medical devices. Many vendors, however, still scramble manually to generate SBOMs, or rely on patchwork documentation. This essay argues that Labrador Labs’ SCM (Software Component Management) solution provides a structured, scalable, and credible way to support transparency, traceability, and trust – from the first build to the final approval. If your device controls lives, and you can’t map your software components, you’ve already lost control. SBOMs aren’t bureaucracy, they’re your credibility, in binary.

Why SBOMs and Why Now

The regulatory driver

In December 2022 the Consolidated Appropriations Act (2023) amended the Federal Food, Drug, and Cosmetic Act by adding section 524B: “Ensuring Cybersecurity of Devices.” That statute mandates that for “cyber devices” (defined as devices with software validated, installed or authorized by the sponsor, which can connect to the internet, and have technological characteristics potentially vulnerable) a pre-market submission must include: a plan for post-market vulnerability management; design/development/maintenance processes to assure cyber-security; and a software bill of materials (SBOM) covering commercial, open-source, and off-the-shelf software components. The effective date for this requirement is March 29, 2023, for pre-market submissions. The updated guidance from the FDA – e.g., “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” – explicitly includes SBOM expectations. In particular Appendix 4 of the guidance lists SBOM among documentation elements.

Thus, the regulatory environment now views SBOM not as optional nice-to-have but as a required element for many device submissions.

The purpose of SBOMs

Why does the FDA care about SBOMs? Because today’s medical devices incorporate large volumes of software, both proprietary code and third-party (open-source and commercial). Each software component is potentially a vector of vulnerability, and the sheer complexity of software supply-chains can obscure risk. An SBOM provides a granular inventory of software components (names, versions, suppliers, dependencies) which enables:

  • Identification of components subject to new vulnerabilities
  • Mapping of which devices include which components (so that remediation or patching can be targeted)
  • Traceability of software from build to field
  • Transparency for regulators, device users, and operators.

FDA describes SBOMs as a “tool to help manage supply chain risk as well as clearly identify and track the software incorporated into a device.” The SBOM must be maintained and updated over the lifecycle of the device, not just at submission.

The challenge for manufacturers

Despite the clarity of the requirement, many device manufacturers struggle. Generating an SBOM often means manually mining build systems, dependency lists, open-source licenses, architectures, static/dynamic code inventories. Many tools were not designed for regulated medical-device environments and manual scramble, version drift, and incomplete traceability are common. If your device “controls lives” (as many do) and you cannot map every software component reliably, you lose control of your cybersecurity posture, remediation ability, and your credibility with the FDA. The SBOM mandate is less about documentation and more about demonstrating you understand what you shipped and can manage what you maintain.

Labrador Labs’ SCM Solution: Overview

What the solution does

Labrador Labs’ SCM solution is designed to provide a software-component management system that supports medical-device manufacturers (MDMs) in building SBOM-capable pipelines. Key features include:

  • Automated scanning of source‐ and binary-code to identify third-party, open-source, and off-the-shelf components.
  • Generation of SBOM outputs in industry-accepted formats (e.g., SPDX, CycloneDX) that support machine readability and downstream vulnerability tracking.
  • Integration with build systems (CI/CD), version control, and artifact repositories so that component inventories remain synchronized with each build.
  • Traceability linking components in the SBOM back to build IDs, versions, bill-of-materials snapshots, and regulatory submission records.
  • A dashboard and reporting capability that surfaces which components are used in which device versions, what their support/patch status is, what known vulnerabilities exist, and whether remediation has been applied.
  • Workflow support for regulated-device QMS (quality-management system) and change-control processes: when a new software component is introduced (or updated/patch applied), the system flags SBOM impact, triggers regulatory/compliance workflows, generates updated SBOM deliverables, and records the revision history.
  • Export capabilities: the device manufacturer can optionally share SBOMs with regulators or customers, and the system maintains revision control and audit trail of SBOM versions.

How it addresses the SBOM requirement

Labrador Labs’ solution maps directly to the regulatory requirements from the FDA and aligns with industry-accepted SBOM practices. Specifically:

  • Because SBOM must include “commercial, open-source, and off-the-shelf software components,” the solution’s scanning of all three categories aligns with that requirement.
  • The solution embeds SBOM generation into build pipelines, so SBOMs are not after-the-fact manual documents but part of the build artefacts, improving timeliness and accuracy.
  • The traceability function supports linking each SBOM version to a specific device version and build, enabling the device manufacturer to answer: “Which components did we ship in build X?” and “Which devices in the field include that component?”
  • The vulnerability-tracking component means the SBOM is not static: it becomes dynamic and useful. When a vulnerability is published in an open-source component, the dashboard shows which devices are impacted, enabling timely remediation and communication, thus supporting the FDA’s expectation of a post-market vulnerability-monitoring plan. (See FDA FAQ Q4)
  • The solution supports export in machine-readable SBOM formats, aligning with FDA’s transparency goals (the guidance emphasises machine-readable formats)
  • It supports revision control and audit trails which align with regulated QMS requirements (device lifecycle, change-control, documentation).

In sum: the solution helps convert SBOM from “manual scramble” to “automated, traceable, credible deliverable”.

The Value Proposition: Transparency, Traceability & Trust

Transparency

Transparency means you and your regulator (or customer) can see what’s inside your device software. It is no longer enough to claim “we use open-source responsibly”; you must show the component list, versions, supplier, and context. The SBOM becomes the transparency instrument. With Labrador Labs’ solution, the SBOM is generated and made visible in a structured form: you can query “which versions of library X are used in device version Y” or “which devices contain component Z”. This turns transparency from aspiration into operational reality.

Traceability

Traceability means you can track the lineage of each software component: when it was introduced, which build(s) it appears in, whether it was updated or patched, which device versions include it, and when a vulnerability was addressed. In regulated medical-device development, traceability is required: you must link requirements → design → implementation → verification → validation → release. Software component traceability is a unique extension into the supply-chain domain. The SCM solution from Labrador Labs embeds traceability by linking SBOM elements to build artifacts, version control, and device releases. Thus when a component is flagged as vulnerable, you can trace the “blast radius” which devices, which customers, which field units and respond accordingly.

Trust

Trust flows from the combination of transparency and traceability. Regulators (FDA or others), customers (hospitals, health systems), and end-users (clinicians, patients) want assurance that the device they rely on is safe, secure, maintained. If you can present a credible SBOM, current vulnerable-component status, patch-plan, and audit trail, you build trust. By contrast, if you cannot map what’s inside your software, or you rely on ad-hoc spreadsheets, you signal risk. In binary form (component list, versions, build-IDs) SBOMs become your credibility. Labrador Labs transforms SBOM from a compliance checkbox into a trust metric.

Implementation Considerations & Best Practices

Integration into the development pipeline

To maximize value the SCM solution should be integrated early in the software lifecycle:

  • At code check-in and build time automatically trigger component scanning and SBOM generation.
  • Link build artifacts (executables, firmware, containers) back to the SBOM snapshot so you can always correlate “build #123 deployed in device v1.0” with “SBOM v2025-09-01”.
  • Use machine-readable formats (SPDX, CycloneDX) so that downstream tooling (vulnerability scanners, risk trackers) can ingest the SBOM.
  • Establish conventions for component naming, versioning, supplier metadata, licensing metadata so SBOMs are consistent and comparable over time.
  • Ensure your QMS and change-control process include updates to SBOM when components are added/changed/removed and document the rationale for change.

Lifecycle maintenance & post-market monitoring

SBOM is not “generate once, submit once.” It must be maintained. Best practices:

  • Monitor vulnerability databases (e.g., CVE, NVD) for components listed in your SBOM and map them to your device inventory. The Labrador Labs platform’s dashboard can flag impacted builds/devices automatically.
  • Update SBOM when software components are patched or replaced and maintain version history and impact analysis (which device versions are affected).
  • Link SBOM change events into your CAPA (corrective and preventive action) or field-safety-corrective action process so your regulatory submission can document real-world deviation or field-impact.
  • Ensure that your labeling, user-documentation, or security/maintenance instructions reflect the SBOM status (or reference it) as part of the cybersecurity transparency piece. The FDA guidance emphasises that manufacturers should use SBOM to help users manage assets and assess impact of vulnerabilities.
  • For any device modifications or firmware updates, assess whether the change impacts cybersecurity or software components; if so, refresh the SBOM, resign build, re-trace risk.

Regulatory submission alignment

When preparing a pre-market submission (e.g., 510(k), PMA, De Novo), you must include the cybersecurity section per the FDA guidance which now expects SBOM for “cyber devices.” To be submission-ready:

  • Bundle the SBOM (machine readable) as part of your cybersecurity documentation.
  • Provide explanation of how SBOM was generated, maintained, and how changes will be controlled.
  • Show linkage between SBOM and device version: e.g., list of builds, version numbers, and SBOM snapshot IDs.
  • Provide your post-market vulnerability management plan, showing how SBOM feeds into vulnerability monitoring.

If your SBOM generation is manual, ad-hoc, or not clearly linked to specific builds/releases, the reviewer may raise questions or delay acceptance. One blog summaries: “An ideal SBOM allows you to identify devices and systems that might be affected by vulnerabilities… and should be kept updated.” Labrador Labs’ SCM solution is designed to give you that linkage.

Organizational and process maturity

The technology is one piece. You also need process maturity:

  • Governance: designate an owner for software component inventory and SBOM lifecycle.
  • Policies: define when and how SBOM generation happens; define minimum metadata (component name, version, vendor, license, date introduced, end-of-support).
  • Training: development, firmware, QA teams must understand the importance of component inventory, licensing, open source implications, version drift.
  • Auditing: internal audits of your SBOM process, build pipeline, and component risk metrics.
  • Supplier management: third-party software/component suppliers must provide metadata or be scanned; your system must account for off-the-shelf or embedded libraries.
    These process-elements combined with the SCM tool anchor your trust and traceability.

How Labrador Labs’ Solution Supports Common Obstacles

Obstacle: Manual spreadsheet SBOMs

Many manufacturers rely on spreadsheets, manual inventory, ad-hoc checklists to build SBOMs after the fact. This is labour-intensive, error-prone, and creates a gap between what you think shipped vs what actually shipped. Labrador Labs’ solution replaces spreadsheets with automated scanning and build-linked SBOM creation. This reduces human error, improves timeliness, and strengthens traceability.

Obstacle: Lack of build-to-field linkage

Even when an SBOM is produced, if it cannot be tied to a specific build version and deployed device, you lack traceability. Labrador Labs links SBOM snapshots to build IDs, firmware version, and device release IDs. If a component later has a vulnerability, you can query “which deployed devices contain build #123 which used component X version v2.3?” and generate targeted remediation or communication.

Obstacle: Keeping SBOM current

A static SBOM created at submission time is insufficient in a dynamic ecosystem of software components. Labrador Labs supports ongoing monitoring, dashboarding of components and vulnerabilities, and triggers when a component changes (version upgrade, patch, or deprecation). This allows you to maintain the SBOM as a living artifact rather than a stale document.

Obstacle: Format and submission-readiness

Regulators expect machine-readable SBOMs (SPDX, CycloneDX), consistent naming/versioning, licensing metadata, etc. Many legacy processes produce ad-hoc documents. Labrador Labs supports export in industry formats, supports metadata fields (component name, version, license, supplier, end-of-support date) and thus aligns with regulatory expectations. (For example: list of “minimum elements” of an SBOM includes component name, version, supplier, support date, known vulnerabilities)

Obstacle: Demonstrating the SBOM process in regulatory submission

When you submit to the FDA you must not only deliver the SBOM but also show how the SBOM was generated, maintained, and linked to your quality system and vulnerability-management process. Labrador Labs supports audit trails, build-pipeline integration, version history, change logs, and vulnerability-impact dashboards. This gives you the “how we do it” story that reinforces credibility.

Use Case: Medical Device Manufacturer with Connected Device

Imagine a company that manufactures a network-enabled infusion pump. The pump control software uses a mix of proprietary code, commercial RTOS, open-source communication libraries, and off-the-shelf firmware modules. The device must connect to hospital networks, receives periodic firmware updates, and must commit to post-market cybersecurity monitoring.

Without a structured SCM/SBOM solution

  • The company produces a “software inventory” spreadsheet at submission time listing high-level modules.
  • When a new open-source library version is introduced, they update the spreadsheet manually and send a “change notice” to the regulator.
  • When a vulnerability in library X version 3.5 is publicly disclosed, they manually search through release records to identify which devices might be affected (which is time-consuming).
  • Their SBOM is in PDF/document form, not machine-readable; they struggle to integrate with vulnerability databases or hospital asset-management systems.
  • During the 510(k submission, the FDA reviewer requests: “How do you map your SBOM to deployed devices and how will you manage patches over device lifetime?” The responses are partial and raise follow-up questions, delaying clearance.

With Labrador Labs’ SCM solution

  • The build pipeline automatically triggers scanning of code and binaries upon each build. An SBOM snapshot is generated (machine-readable), tagged with build ID, component list, version info, supplier metadata, and stored in the SCM repository.
  • Release notes include a link to the SBOM snapshot. The build is traced to the specific device version and firmware version.
  • When device gets deployed, the asset team uses the same SBOM metadata to tag the device: e.g., infusion pump model X firmware v2.1 includes build #567 and SBOM snapshot 2025-09-15.
  • A vulnerability database feed is integrated: when library X v3.5 receives CVE-2025-1234, the dashboard flags that SBOM snapshot 2025-09-15 (and all devices containing it) include that component. The system generates a list of affected devices and triggers a patch-workflow (change-control, regulatory update, field-notice if needed).
  • For regulatory submission the company exports the SBOM in SPDX format and includes, in the cybersecurity section, the process description: how the SBOM is generated, how traces are maintained, how updates are tracked, how vulnerability monitoring is conducted. The SBOM is linked to the device version as required by the FDA guidance. This materially shortens the review cycle and increases confidence.
  • Post-market the company continues to maintain SBOM changes, tracks component sunsets (end-of-support dates) and can demonstrate to customers/hospitals that the device software composition is managed, monitored, and controlled.

Thus the SCM solution turns SBOM from a compliance burden into a competitive differentiator and risk-mitigation asset.

Strategic Advantages for Device Manufacturers

Beyond regulatory compliance, implementing an SCM/SBOM-oriented solution provides strategic advantages.

Speed to market

When regulatory reviewers see that SBOM, build traceability, vulnerability-monitoring plans and change-control workflows are in place, your clearance cycle may be faster. Since the FDA Guidance emphasizes SBOM in submissions (Appendix 4) and that the SBOM is a tool for risk assessment, a well-structured SBOM will reduce back-and-forth. An SCM solution which embeds SBOM generation into your workflow means you don’t scramble manually at submission time.

Reduced risk and liability

By mapping all software components, you reduce “unknowns” in your software supply chain. Unknown components or undocumented dependencies are risk-hotspots – if a vulnerability arises you may be unable to respond or may face a field-action. Having an SBOM and tracking infrastructure helps you limit risk, reduce remedial cost, and maintain credibility with regulators and customers.

Customer confidence and competitive differentiation

Hospitals and health systems are increasingly aware of cybersecurity supply-chain risks. If you can demonstrate to your customers that you maintain full component transparency (via SBOM) and can rapidly respond to component-level vulnerabilities, you stand out. SBOM becomes part of your value proposition: “We can show you exactly what’s in our device software, how we maintain it, and how we will respond to vulnerabilities.” That trust can be a differentiator when device purchasers evaluate vendors.

Lifecycle cost savings

Manual SBOM generation is labor-intensive, error-prone, and inefficient. The ongoing costs of tracking components, responding to vulnerabilities, auditing spreadsheets, reconciling build records, are high. By automating component scanning, SBOM generation, dashboarding, and linking to build pipelines you realize cost savings over the product lifecycle: faster response, fewer surprises, fewer field-actions.

Regulatory alignment and future-proofing

Since the FDA’s cybersecurity and SBOM expectations are evolving (for example the June 2025 updated guidance) having a robust component-management infrastructure ensures you are better positioned for future regulator demands. Rather than re-inventing SBOM workflows per submission, you have a repeatable, audited process under your control.

Implementation Roadmap for Labrador Labs’ Solution

Here is a recommended phased roadmap for deploying Labrador Labs’ SCM solution in a medical-device context.

Phase 1: Baseline and pilot

  • Inventory existing device software: scan current builds/firmware, identify third-party/open-source/off-the-shelf components, produce initial SBOMs.
  • Define policies & governance: establish ownership of SBOM process, define minimum component metadata (name, version, supplier, license, date introduced, end-of-support).
  • Integrate the SCM tool: link with version control (git), artifact repository, CI/CD system. Configure initial dashboard.
  • Pilot with one device or firmware version: generate SBOM automatically for each build, link to build ID and release version, test vulnerability scanning and dashboard functionality.

Phase 2: Scale and link to QMS

  • Expand across device portfolio: ensure all product lines are covered.
  • Integrate change-control/approval workflows: when a component is updated or new third-party library introduced, trigger SBOM refresh and regulatory/quality review.
  • Link to CAPA and vulnerability-monitoring process: use tool to alert when a component in SBOM is vulnerable and schedule remediation workflow.
  • Audit trail and documentation: enable export of SBOMs in required formats, log history of SBOM changes, link each SBOM version to a build release and device version.

Phase 3: Submission-ready and field maintenance

  • For upcoming pre-market submission: export SBOM in machine-readable format, include SBOM generation and maintenance process in cybersecurity section of submission.
  • Ensure field devices: tag deployed devices with SBOM version, maintain mapping between deployed devices and SBOM snapshot.
  • Post-market monitoring: set up ongoing feed of vulnerability data, automate alerts linking to SBOM component lists, prepare remediation/patch plans, prepare field-notification workflows if needed.
  • Reporting and customer transparency: provide SBOM snapshot or summary to hospitals/customers (as appropriate) to improve customer trust, and enable asset-management integration in hospital systems.

Phase 4: Continuous improvement and audit

  • Review SBOM process annually (or more frequent) as part of internal audits.
  • Monitor regulatory updates (e.g., FDA guidance changes) and update your SBOM process accordingly.
  • Explore advanced analytics: e.g., SBOM-based risk scoring, component sunset/risk modelling, predictive vulnerability exposure.
  • For each new device version or major update, validate that SBOM generation remains effective and build-linkage remains correct.

Risk Considerations and Mitigation

Risk: Incomplete component detection

Even an automated SCM tool may miss some components (especially binary blobs, firmware modules, proprietary modules without metadata). Mitigation: supplement automated scanning with manual review (especially for firmware and embedded modules), maintain granular component inventory, and ensure metadata capture for custom modules.

Risk: Component metadata accuracy

SBOM utility depends on accurate metadata (version, supplier, end-of-support). If metadata is missing or out-of-date, SBOM loses value. Mitigation: define mandatory metadata fields in your process, enforce vendor/supplier declarations, regularly refresh component information, integrate public-vulnerability feeds.

Risk: Linking SBOM to field devices

If you lack accurate mapping between SBOM snapshots and deployed devices (serial numbers, firmware versions, build IDs) you cannot quickly respond to vulnerabilities. Mitigation: design your asset-management process in the field to tag devices with firmware version/build, maintain central database linking devices to SBOM snapshot.

Risk: Regulatory submission mismatch

If the SBOM you submit does not clearly reflect the build you shipped, or if you cannot show process for updates/maintenance, the regulator may raise issues or delay review. Mitigation: ensure your submission references the exact build/firmware version, include process description, provide audit trail of SBOM generation, maintenance, update.

Risk: Organizational resistance / cultural change

Moving from ad-hoc spreadsheets to automated SCM/SBOM means process change. Mitigation: provide training, highlight benefits (speed, risk reduction, customer trust), assign governance and accountability, start small pilot to demonstrate ROI.

Risk: Licensing or third-party-component legal issues

SBOM may expose use of open-source libraries with restrictive licenses or deprecated components. Mitigation: include licensing metadata in SBOM, maintain license-compliance process, review deprecated or unsupported components and plan remediation.

Why SBOMs Are Not Mere Bureaucracy

It is tempting to view SBOMs as yet another regulatory burden or paperwork exercise. But that perspective is misguided. The real purpose of SBOMs is operational: to give device manufacturers control over their software supply chain, to reduce risk, to enable rapid response to vulnerabilities, and to underpin credibility with regulators and customers. If your device provides life-critical functions (e.g., infusion pumps, pacemakers, imaging devices), software vulnerabilities are not abstract – they can compromise patient safety, device availability, clinical workflows, or institutional IT systems. The FDA underscores this: cybersecurity is patient safety. If you cannot map your components, you cannot answer the question “Which of our devices are impacted by vulnerability X?” That means you lose control. In effect, SBOMs are your credibility, in binary form. The Labrador Labs SCM solution helps you turn SBOM from “compliance checkbox” into “operational capability.”

The era of disconnected spreadsheets, manual dependency-lists, and post-hoc component audits is over for medical-device software manufacturers. The FDA now expects SBOMs as part of cybersecurity risk-management for pre-market submissions (and lifecycle management). If you cannot map what’s inside your software, you cannot reliably respond to vulnerabilities, you cannot demonstrate to the regulator that you control your supply chain, and you risk device clearance delays, field-actions, or worse.

By implementing Labrador Labs’ SCM solution you gain the infrastructure to generate, maintain, trace, and report SBOMs in a scalable way. You embed transparency, link each build to each SBOM snapshot, maintain live monitoring of components, and support your QMS and regulatory workflows. You convert SBOM from an after-thought to a competitive strength. The investment in SCM/SBOM is not only compliance, it is risk mitigation, brand differentiation, lifecycle efficiency, and trust building.

If your device controls lives, and you can’t map your software components – you’ve already lost control. But with the right process and tooling, such as Labrador Labs’ SCM solution, you regain control. SBOMs aren’t bureaucracy, they’re your credibility, in binary.