The U.S. Food & Drug Administration (FDA) SBOM mandate is changing the game for medical device manufacturers, pushing for greater transparency and cybersecurity in an increasingly connected world. Gone are the days of manual, outdated processes for tracking software components. Today, manufacturers must provide a real-time, comprehensive view of all the software running inside their devices.
As cybersecurity threats continue to rise, the need for transparency isn’t just a regulatory hoop to jump through—it’s essential for protecting patient safety and maintaining compliance. This article will walk you through the specifics of the FDA’s SBOM requirements, why they matter, and how leveraging tools like Software Composition Analysis (SCA) can make compliance easier. By the end, you’ll have a roadmap for staying compliant and ensuring your devices are secure, up-to-date, and ready for the market.
SBOMs are Now Mandatory – Here’s Why
Medical devices are increasingly reliant on complex software systems, making them vulnerable to cybersecurity threats. Recognizing this, the FDA introduced SBOM requirements to ensure that all software components embedded in these devices are fully transparent and accounted for. This isn’t just a compliance box to tick—it’s a proactive step toward building a safer healthcare environment where manufacturers, regulators, and patients can trust the technology that drives medical devices.
The FDA’s Mandate
The FDA’s SBOM requirements ensure that manufacturers disclose detailed information about the software powering their devices, whether it’s open-source, proprietary, or third-party. The SBOM must be machine-readable and follow recognized formats like SPDX or CycloneDX, giving all parties—manufacturers, regulators, and auditors—a standardized way to assess the software.
What’s at Stake
Failing to comply with SBOM standards can have serious consequences. Beyond delaying product approvals, non-compliance can expose devices to cybersecurity threats, leading to costly recalls, legal repercussions, or even risks to patient safety. The FDA’s continuous oversight means manufacturers must maintain up-to-date SBOMs, respond swiftly to new vulnerabilities, and demonstrate proactive risk management throughout the device’s lifecycle. Ultimately, the mandate provides manufacturers with the opportunity to enhance their security posture and avoid the risks of outdated software.
Now that we’ve covered why SBOMs are critical, let’s dive into what exactly needs to be included.
SBOM 101 – The FDA’s checklist
An SBOM is more than a simple list of software components. To meet FDA standards, it must offer a detailed, structured overview of every software component running on a medical device. So, what exactly does the FDA expect?
SBOM Essentials
Here are the key components that must be included in an SBOM to meet FDA standards—and why they matter for both compliance and security.
1. Supplier information
What to include: Identify the source of each software component—open-source, proprietary, or third-party.
Why? Knowing the supplier helps manage licensing and legal risks, while ensuring that outdated or abandoned components don’t introduce security vulnerabilities.
2. Component versions
What to include: List the exact version number of each component.
Why? Different software versions have different vulnerabilities. Knowing your component versions is like knowing which key opens your front door – because using the wrong one might just set off the alarm (or worse, let the hackers in!)
3. Dependencies
What to include: Outline how software components rely on one another.
Why? Vulnerabilities in one component can affect others. Documenting dependencies helps identify the ripple effects of software issues.
4. Timestamps
What to include: Include the creation date and timestamp for the SBOM.
Why? Timestamps ensure that the SBOM reflects the current state of the software, helping track when new vulnerabilities arise.
5. Vulnerability assessments
What to include: List known vulnerabilities and mitigation measures for each component.
Why? The FDA requires manufacturers to demonstrate active management of software risks to prevent cybersecurity threats.
6. Lifecycle information
What to include: Provide details on whether a component is maintained, discontinued, or unsupported.
Why? Unsupported software components pose risks, as they no longer receive security updates. Lifecycle information helps assess long-term security risks.
7. Machine-readable formats
Submitting SBOMs in machine-readable formats like SPDX or CycloneDX ensures the data is accessible and automatically processed, reducing human error and simplifying the auditing process.
Who’s in the Spotlight?
The SBOM mandate applies to medical devices classified as “cyber devices,” which connect to networks, use embedded software, or are vulnerable to cybersecurity threats. Examples include pacemakers, insulin pumps, and imaging systems – devices that are not just dependent on software but also connected to the internet, making them targets for cyberattacks.
Who Must Comply
If your device connects to the internet, uses software, or has a ‘please update’ notification flashing, congratulations – it’s officially a ‘cyber device’ in the FDA’s eyes. According to the FDA, a cyber device is any product that:
- Connects to the internet or a network: Devices like insulin pumps, pacemakers, and imaging systems that use Wi-Fi, Bluetooth, or other network protocols are vulnerable to cyberattacks.
- Relies on software for functionality: Any device with embedded software crucial to its operation, whether open-source or proprietary, falls under the mandate.
- Could be exposed to cybersecurity threats: Devices storing sensitive data or interfacing with external systems are at risk of breaches, and the FDA mandates full software transparency to mitigate these risks.
By focusing on cyber devices, the FDA aims to create a standardized process that ensures comprehensive software transparency, helping manufacturers identify and address vulnerabilities before they lead to major incidents.
Managing Cybersecurity Risks
The FDA’s SBOM mandate isn’t just about software transparency – it’s about actively managing the cybersecurity risks associated with complex software used in medical devices. In the following sections, we’ll explore the key steps required to manage these risks, from conducting vulnerability assessments to navigating legal risks related to software licensing.
Vulnerability Assessments
SBOMs must include a detailed review of known vulnerabilities for each software component. Manufacturers must identify risks, assess their impact on the device, and outline steps to mitigate them. The goal isn’t to eliminate all risks but to demonstrate proactive risk management, helping prevent minor issues from becoming major cybersecurity threats. This ongoing process is essential for maintaining compliance and ensuring device safety.
Using VEX (Vulnerability Exploitability eXchange)
The FDA encourages manufacturers to use VEX statements to clarify the status of vulnerabilities. VEX helps explain whether a vulnerability is being mitigated or poses no immediate risk. This provides critical context for regulators, streamlining the review process and reassuring healthcare providers and patients about the device’s security.
Avoiding Legal Risks
Using open-source software can be a cost-effective solution for medical device manufacturers, but it comes with risks. SBOMs help manufacturers keep track of which software components are being used and whether they comply with the necessary licensing terms. By utilizing SBOMs generated through Software Composition Analysis (SCA) tools and supported by expert software auditors, manufacturers can ensure they are meeting all licensing requirements, protecting their intellectual property, and avoiding costly legal consequences. This proactive approach helps manufacturers avoid lawsuits and regulatory setbacks, allowing them to focus on device safety and innovation.
How SCA Tools Manage SBOM Compliance
The FDA’s SBOM mandate demands high transparency and detail in software components used in medical devices. Managing this manually can be overwhelming, especially with complex software systems. That’s where Software Composition Analysis (SCA) tools come in—automating SBOM creation, management, and compliance. SCA tools reduce manual effort while ensuring SBOMs are accurate, up-to-date, and FDA-compliant.
Let’s explore how SCA tools streamline this process and why they’re essential for compliance.
Automated SBOM Generation
SCA tools automate SBOM creation by scanning all software components, including third-party and open-source ones that are often missed manually. This ensures a comprehensive, accurate inventory without the need for tedious manual documentation.
Manual SBOM creation is time-consuming and prone to errors, especially as software evolves. Automation captures every component accurately, saving time, reducing human error, and ensuring FDA compliance.
Real-Time Monitoring
SCA tools continuously monitor software components in real-time, automatically updating the SBOM as new vulnerabilities are discovered. This ensures the SBOM is always current, giving manufacturers immediate insights into potential risks. Since cybersecurity threats evolve quickly, real-time monitoring allows manufacturers to stay compliant throughout the device’s lifecycle, responding to threats as they arise and protecting the device’s integrity.
Source SBOMs
SCA tools, with the help of expert auditors, create Source SBOMs that provide a complete and detailed inventory of software components, including dependencies and third-party software. These Source SBOMs go deeper than surface-level scans, offering manufacturers full visibility of potential risks.
Source SBOMs align with the Cybersecurity and Infrastructure Security Agency (CISA)’s six types of SBOMs, which cover software identity, dependency relationships, software provenance, development integrity, build integrity, and operational integrity. Adhering to CISA’s framework not only meets FDA requirements but also sets a higher standard for cybersecurity across industries, helping manufacturers better manage risks and improve compliance.
The SBOM Ripple Effect
The FDA’s SBOM mandate as a blueprint for other industries
As we’ve seen, tools like SCA not only simplify compliance but also enhance security for medical devices. But the impact of SBOMs goes far beyond healthcare.
The FDA’s SBOM mandate is setting the stage for other industries to adopt similar standards. With cybersecurity threats rising in all sectors, transparency and proactive risk management are becoming essential. While the focus has been on medical devices, industries like automotive, aviation, and manufacturing are starting to recognize the value of SBOMs for managing software vulnerabilities and protecting connected devices.
Beyond Medical Devices
The FDA’s SBOM mandate serves as a potential model for other industries where software safety is critical. In automotive, software controls everything from engine performance to navigation. Similarly, aviation relies on software for flight control and communication systems. These sectors face similar cybersecurity risks as medical devices, and adopting SBOM practices can help identify and address vulnerabilities before they lead to serious harm.
Any industry reliant on software, particularly connected devices, is likely to follow the FDA’s lead.
Global Regulatory Trends: SBOMs as a Worldwide Standard
The FDA’s mandate is part of a broader shift toward transparency in cybersecurity. Globally, regulators are recognizing the importance of SBOMs in managing software security risks. The EU Cyber Resilience Act will soon require SBOMs for connected devices, and similar regulations are emerging in other regions like Asia and South America.
It’s becoming clear that SBOMs will soon be a global standard, ensuring software security across industries and regulatory landscapes.
