What Is A Software Bill of Materials (SBOM) as Required By Section 524B(b)(3) of the FD&C Act

A Software Bill of Materials (SBOM) is crucial in medical device software development. This article aims to comprehensively understand SBOM and its importance, as required under Section 524B(b)(3). We will delve into the basics of SBOM, its legal framework, its relationship with Section 524B(b)(3), its implementation process, and future implications.

Understanding the Basics of Software Bill of Materials (SBOM)

Before we explore the legal aspects of SBOM, let’s define what it entails. In a nutshell, SBOM is a detailed inventory that outlines a software system’s components and dependencies. It records all the ingredients that go into creating a software application, much like a bill of materials in manufacturing or construction.

When diving deeper into the concept of SBOM, it becomes evident that this inventory not only lists the components but also provides crucial details about each element. This includes version numbers, licensing information, and any known security vulnerabilities associated with the specific component. Organizations can effectively manage and secure their software supply chain with this granularity level.

Defining Software Bill of Materials (SBOM)

In essence, SBOM provides a transparent view of the software supply chain, enabling organizations to assess potential security vulnerabilities effectively and mitigate associated risks. It records information such as open-source and third-party components, libraries, frameworks, and dependencies used to create a software system.

An SBOM fosters transparency and accountability within the software development process. By having a comprehensive list of all components used in a software project, developers can ensure compliance with licensing requirements and avoid any legal ramifications that may arise from using components with conflicting licenses.

Organizations such as the OpenSSF are working to help secure open-source software.

The Importance of SBOM in Software Development

Software development has evolved into a complex ecosystem with numerous interdependencies on external components and libraries. Organizations are susceptible to security breaches, licensing compliance issues, and other operational complexities without a proper understanding of these dependencies.

SBOM equips developers, regulators, and end-users with the necessary knowledge to make informed decisions about the software they are developing, procuring, or utilizing. It enables organizations to proactively identify and address vulnerabilities, ensuring a more secure and reliable software landscape.

The implementation of SBOM can streamline the process of software updates and patches. Organizations can quickly identify which parts of the software need updating when security vulnerabilities are discovered by having a clear overview of all components and their relationships. This proactive approach enhances security and minimizes the potential impact of cyber threats on the software ecosystem.

The Legal Framework: Section 524B(b)(3) of the FD&C Act

To comprehend the significance of SBOM, it is essential to understand the legal framework under which it operates. Section 524B(b)(3), introduced by the government, mandates the inclusion of SBOM in software development processes. Let’s explore this section in more detail.

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An Overview of Section 524B(b)(3)

Section 524B(b)(2) insists that medical device manufacturers integrate robust cybersecurity measures into their product development processes. Section 524B(b)(3) provides more detail to 524B(b)(2) by stipulating that software vendors must provide an accurate and up-to-date SBOM for all the software they supply. This requirement aims to enhance cybersecurity and improve response strategies, enabling organizations to assess and address vulnerabilities swiftly.

Leading regulatory bodies, such as the U.S. Food & Drug Administration (FDA) and the Cybersecurity and Infrastructure Security Agency (CISA), have endorsed the incorporation of SBOM as part of software development and procurement regulations.

The Role of Section 524B(b)(3) in SBOM

Section 524B(b)(3) serves as a catalyst for fostering transparency and accountability in the software industry. By mandating the creation and disclosure of an SBOM, it empowers organizations to establish a strong foundation for software security, compliance, and risk management.

Real-world examples demonstrate the positive impact of Section 524B(b)(3). In 2017, Equifax, a renowned credit reporting agency, experienced a massive data breach, compromising the personal information of millions. This incident highlighted the urgent need for robust cybersecurity measures, including the implementation of SBOM, to prevent and mitigate such breaches in the future.

Section 524B(b)(3) benefits organizations and consumers. By including SBOM in software development processes, consumers gain greater visibility into the components and dependencies of the software they use. This knowledge allows them to make informed decisions about the software’s security and privacy implications, ultimately protecting their personal information.

Section 524B(b)(3) has spurred innovation in the software industry. As software vendors strive to comply with the SBOM requirement, they must adopt more robust development practices and implement stronger security measures. This has led to new tools and technologies that facilitate the creation and management of SBOMs, further advancing software security.

The Relationship Between SBOM and Section 524B(b)(3)

It is important to understand the relationship between SBOM and Section 524B(b)(3) to understand their combined significance better.

When delving into the intricacies of the Software Bill of Materials (SBOM) and its correlation with Section 524B(b)(3) of the legal framework, it becomes evident that SBOM plays a pivotal role in compliance and cybersecurity. SBOM serves as a detailed inventory of software components, dependencies, and their origins, providing a comprehensive view of the software supply chain. This transparency is crucial for organizations to comply with Section 524B(b)(3) requirements, which mandate the disclosure of software composition and potential vulnerabilities.

How SBOM Complies with Section 524B(b)(3)

By implementing SBOM, organizations comply with the requirements outlined in Section 524B(b)(3). Including an accurate and up-to-date SBOM ensures transparency and facilitates effective risk management, contributing to the security and integrity of software systems.

Companies like Microsoft have recognized the value of SBOM and have voluntarily adopted it as a best practice, setting an example for others to follow. This proactive approach has been instrumental in minimizing security risks and fostering user trust.

The alignment of SBOM with Section 524B(b)(3) enhances cybersecurity measures and streamlines regulatory compliance. By proactively disclosing software components and vulnerabilities through SBOM, organizations demonstrate a commitment to regulatory standards and proactive risk mitigation strategies.

The Implications of Non-Compliance

Failure to comply with Section 524B(b)(3) can severely affect software vendors. Non-compliance exposes organizations to legal liabilities, tarnishes their reputation, erodes customer trust, and impedes business growth.

A notable case involving non-compliance is the SolarWinds supply chain attack in 2020. Hackers successfully infiltrated SolarWinds’ software supply chain and injected malware into their software updates, causing widespread repercussions. This incident prompted increased scrutiny and emphasized the urgency of SBOM implementation to prevent such attacks.

In essence, the intersection of SBOM and Section 524B(b)(3) underscores the critical need for transparency, accountability, and proactive risk management in software development and distribution. Embracing SBOM ensures compliance with regulatory mandates and fortifies cybersecurity defenses, ultimately safeguarding organizations and their stakeholders from potential threats and vulnerabilities.

Implementing SBOM as Required Under Section 524B(b)(3)

Now that we understand the importance and legal context of SBOM, let’s explore the steps that organizations need to take to implement it effectively.

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Software Bill of Materials (SBOM) is crucial in ensuring transparency and security in software supply chains. By providing a detailed inventory of software components and dependencies, SBOM enables organizations to track and manage potential vulnerabilities effectively.

Steps to Implement SBOM

1. Inventory Assessment: Begin by identifying all software components and dependencies used in your systems. This includes open-source libraries, third-party modules, and custom code.

2. Documentation: Create a comprehensive record of all software components, including version numbers and licensing information.

3. Maintenance and Updates: Regularly review and update the SBOM to reflect changes in software components and dependencies. This ensures that the SBOM remains accurate and reliable.

Establishing a robust SBOM process is essential for organizations looking to enhance their cybersecurity posture and comply with regulatory requirements.

Challenges and Solutions in SBOM Implementation

Implementing SBOM may present some challenges for organizations, such as the complexity of software ecosystems, managing large-scale inventories, and ensuring compliance with licensing obligations. However, solutions are available to overcome these obstacles.

Automated tools and platforms can streamline SBOM creation, maintenance, and updates, simplifying the process for organizations. These tools can also provide insights into potential security risks and licensing issues, facilitating proactive risk management and compliance.

Collaboration with software vendors and industry partners can also aid in successfully implementing SBOM. By fostering relationships with key stakeholders, organizations can gain access to timely updates and information regarding software components, further strengthening their SBOM practices.

The Future of SBOM and Section 524B(b)(3)

As technology and software development continue to evolve, it is essential to consider the future implications of SBOM and Section 524B(b)(3).

Predicted Changes in SBOM Requirements

Given the evolving threat landscape and the increasing recognition of the importance of software security and transparency, it is likely that SBOM requirements will continue to evolve. Regulatory bodies may introduce additional guidelines or standards, addressing emerging risks and addressing the challenges faced by organizations.

One potential change in SBOM requirements could include more granular information about software components. Currently, SBOMs provide a high-level overview of the software supply chain. Still, future iterations may require organizations to provide detailed information about each component, including its origin, version, and any known vulnerabilities. This level of transparency would enable organizations to assess better the security risks associated with their software and take proactive measures to mitigate them.

The Impact of Future Legislation on SBOM

Future legislation can significantly impact SBOM implementation. Section 524B(b)(3) demonstrates that well-designed regulations can potentially drive positive change and foster a more secure and transparent software ecosystem. Organizations should stay informed and adapt their practices to ensure compliance and reap the associated benefits.

Looking ahead, future legislation may focus on mandating SBOMs and incentivize their adoption. Governments and regulatory bodies may offer tax breaks or other financial incentives to organizations committed to software transparency and security. This could encourage more widespread adoption of SBOMs and create a culture of accountability within the software industry.

Future legislation may also address the issue of liability regarding software vulnerabilities. Section 524B(b)(3) already provides some protection for organizations that disclose vulnerabilities in their software. Still, future regulations could further clarify the responsibilities and liabilities of software vendors, developers, and users. This would help establish a clear framework for accountability and encourage collaboration between stakeholders to improve software security collectively.


SBOM plays a pivotal role in software development and security, fulfilling the requirements outlined in Section 524B(b)(3). By implementing SBOM, organizations enhance transparency, facilitate risk management, and comply with regulations. Although initial implementation may pose challenges, the availability of automated tools and industry-wide collaboration ensures a smoother transition. The future of SBOM holds promising changes and increased recognition, bolstering software security and trust.

As the digital landscape evolves and software transparency and security become paramount, ensuring your organization complies with SBOM requirements is critical. Blue Goat Cyber, a Veteran-Owned business, specializes in B2B cybersecurity services tailored to meet these needs, including medical device cybersecurity, HIPAA and FDA compliance, and various penetration testing services. Don’t leave your cybersecurity to chance. Contact us today for cybersecurity help and safeguard your business with the expertise of Blue Goat Cyber.

Check out our medical device cybersecurity premarket submission FDA compliance package.

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Christian Espinosa

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