The role of software has become an important aspect of the operation of medical equipment. Modern products based on connected imaging systems to Software as a Medical Device are based on a complex software stack, which may contain commercial, open-source, and third-party products. On the one hand, this software allows innovation; however, on the other hand, it has cybersecurity threats, which may have a direct impact on patient safety.
To curb such risks, the U.S. Food and Drug Administration has prioritized software supply chain transparency as a regulation. At this point, FDA SBOM requirements come in. SBoM provides an overview of the software elements utilized in a medical device, and manufacturing allows it to determine the location of vulnerabilities.
FDA anticipations regarding SBOMs have evidently gotten past fundamental records by the year 2026. FDA is considering SBOMs to be a subset of an overall cybersecurity capability that proves the capacity of a manufacturer to recognize vulnerabilities, evaluate risk, and react effectively throughout the product life cycle. Entries where SBOMs are viewed as a completed file, as opposed to a continuous process, have an increased chance of delay in the review or the decision not to accept.
To medical device manufacturers in the United States, knowledge of FDA SBOM, SBOM FDA and associated cybersecurity expectations is a necessity as a compliance strategy, to support post-market obligations and consumer confidence in a more software-intensive healthcare setting.
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What is a Software Bill of Materials (SBOM) under FDA Regulations?
An SBOM is a formal document of software elements that constitute a medical device, commonly known as a Software Bill of Materials. An SBOM in the FDA cybersecurity regulations is supposed to offer explicit transparency of all software components that may constitute a cybersecurity risk, such as business software, open-source audits, and off-the-shelf libraries.
The U.S. Food and Drug Administration has a different view of an SBOM, which is not an inventory list. It is independent evidence that a manufacturer is also aware of its software supply chain and can deal with risks involved with third-party dependencies. This goes along with a wider scope of the FDA in ascertaining the safety and effectiveness of devices during their lifecycle.
A notable difference under the FDA SBOM requirements is that SBOMs should be kept for a period. The SBOM must change with the changes in software as it is updated, patched or modified. The current accuracy provides quicker evaluation in the case of the novelties of vulnerability revelation and aids in quicker decisions of remediation.
In the real world, an SBOM FDA submission is best done using a machine-readable submission, meeting established standards, and linked to vulnerability assessment and risk management processes. Under such a deployment, the SBOM is a component of medical device cybersecurity as opposed to a compliance artefact.
Regulatory Background Behind FDA SBOM Requirements
The current approach of FDA towards SBOMs has been developed over the years due to the rise in cybersecurity risks associated with the use of medical devices. With the increased complexity and interconnectedness of software, regulators started to appreciate that there had to be visibility of the components of software so that patient safety could be safeguarded.
The major regulatory changes that influenced FDA SBOM requirements entail:
- FDA cybersecurity guidelines that were released early and encouraged, but did not require, software risk disclosure.
- Increasing interest in breaches of the software supply chain in healthcare systems.
- Laws in the United States that give the FDA the right to impose cybersecurity measures.
A significant shift occurred late in 2022, when Congress gave the FDA the authority to require information on cybersecurity in premarket submissions of medical devices. This mandate allowed the FDA to require SBOMs and associated documentation on paper as opposed to considering it as a best practice.
The U.S. Food and Drug Administration published its Final Medical Device Cybersecurity Guidance (2026). This direction provided that:
- There are medical devices that need to have an SBOM during premarket submissions.
- Cybersecurity documentation has to show the continuous risk management processes.
- The FDA may reject submissions which do not contain full and proper cybersecurity information.
Since that time, the FDA has explained the process it uses in evaluating SBOMs during review. It is no longer about listing an SBOM file in isolation, but demonstrating how the SBOM can be used to support vulnerability assessment, remediation, and post-market monitoring.
There is one thing that can be made clear by this regulatory foundation by 2026. SBOM is not a document that is created once and never updated again as a compliance document, but as an element of a bigger, more comprehensive cybersecurity strategy.
Did the FDA Remove or Reduce SBOM Requirements?
The medical device industry has been confused about whether FDA removed or relaxed the requirements of SBOM. To a great extent, this misunderstanding is due to modifications in the way the FDA examines and uses SBOMs in premarket submissions rather than the actual backtracking of the requirement.
As a matter of fact, the U.S. Food and Drug Administration still requires SBOMs on medical devices that are being used. The only difference is the focus on the utilization and assessment of SBOMs.
Why the Confusion Exists
A variety of aspects led to the assumption that the requirements of SBOM were decreased:
- The FDA guidance stated that justification of cybersecurity information does not always have to be included directly on the SBOM file.
- Increased flexibility was also added to the ways in which the documentation related to SBOM can be submitted.
- The reviewers started paying more attention to the risk management results instead of SBOM format in isolation.
These changes were aimed at making it more transparent and minimizing the requirements to submit your information to the office, not to discard SBOM expectations.
What the FDA Actually Changed
The FDA tightened its strategy in the following aspects:
- SBOMs are analyzed within the framework of cybersecurity risk management in general.
- The supporting materials, including vulnerability tests, can be provided separately from SBOM.
- Of more concern is the question of whether the SBOM facilitates the identification and response to vulnerabilities.
What Did Not Change
Even with these improvements, there are several fundamental expectations which are here to stay:
- There remains the need for an SBOM to cover the applicable cyber devices.
- SBOM should be machine-readable, complete and accurate.
- The manufacturers have to be able to show that there is active utilization of SBOM data to mitigate cybersecurity risk.
Which Medical Devices Fall Under FDA SBOM Mandates?
FDA SBOM does not apply to every medical device. The need to have an SBOM is determined by the nature of the device as well as the time when the regulatory submission is made. This scope is necessary to know when SBOM documentation is required.
Which Medical Devices Are Covered
The FDA applies the requirements of SBOM to the devices that it considers cyber devices. A cyber device is typically characterized by the following characteristics:
- Software is included with the device: The device has software that is certified, installed or approved by the manufacturer, either by the device itself or included in the device.
- Connectivity is available: The device can be connected to the internet or any other system, either in the same area or remotely.
- There is a risk of cybersecurity: The device has technological characteristics that may be susceptible to cybersecurity threats.
This definition implies that the SBOM requirements are relevant to a large variety of products, such as:
- Embedded devices or devices that contain operating systems or firmware.
- Medical equipment that is network-connected.
- Devices based on third-party or open source software components.
The manufacturers who are unsure about whether their product qualifies as a cyber device are advised to request clarification from the Food and Drug Administration in the U.S.
When FDA SBOM Requirements Apply
The issue of timing is critical in the applicability of SBOM. The FDA SBOM requirements are applicable in the following situations:
- Premarket submissions done on or after March 29, 2023.
- New submissions due to major changes in the software of a device that was previously accepted.
- Software additions and connectivity additions, which update the device with new software components.
SBOM and accompanying cybersecurity information must be included even in the case of devices that are already on the market, but changes are needed that necessitate a new premarket submission. Consequently, the SBOM requirements frequently go far beyond what was initially approved for the product.
Knowing the scope of devices and their time of submission assists the manufacturers in planning the SBOM development appropriately and prevents any sudden regulatory delays.
Premarket Submissions That Require FDA SBOMs
The FDA SBOM requirements are applicable in the premarket review process of medical devices, which are classified as a cyber device. The SBOM is presented as the larger package of cybersecurity documentation and is reviewed together with risk management and software documentation.
SBOMs are required by the U.S. Food and Drug Administration in a variety of premarket submissions in which software is involved in the operation or connectivity of the device.
Premarket Submission Types in Scope
When the device is considered a cyber device, it is required to be submitted through the following pathways:
- 510(k) applications: This is necessary when substantial equivalence to a legally marketed device is to be shown. SBOMs assist the reviewers in evaluating whether new or uncontrolled cybersecurity risks are introduced by the software components.
- De Novo applications: Applied when the device is novel or has low to moderate risk, and does not have a predicate. SBOMs prove useful in this case, particularly since no prior history of devices is to be referred to.
- Premarket Approval applications: SBOMs are used to help better assess software risk and long-term cybersecurity controls in the case of high-risk devices.
- Other types of submissions that are relevant: There are also some other types of submissions that need SBOMs in case software changes have an impact on cybersecurity risk.
How SBOMs Fit Into the Submission Package
An SBOM is not presented on its own. It is generally audited along with:
- Risk assessment of cybersecurity
- Software documentation and architecture descriptions
- Vulnerability management and disclosure policy.
- Developing and maintaining processes securely.
The FDA reviewers seek consistency in these materials. Failure of an SBOM to conform to software documentation or risk assessments should bring up a concern during review.
Core Pillars of FDA SBOM Requirements
Producing a list of software components is not the only requirement that FDA SBOM requirements are constructed based on. The FDA reviews SBOMs as a subset of a wider system of cybersecurity expectations that aim to demonstrate that their manufacturers have knowledge of, control, and supervise the risks associated with software across the device lifecycle.
According to the FDA directions and industry comprehension, these expectations can be summarized into a number of pillars.
The SBOM Itself
The SBOM document lies at the core of the requirements.
- It has to list all of the software elements utilized by the device.
- These are commercial software, open software, as well as off-the-shelf components.
- SBOM must provide a precise reflection of the deployed software in the device.
The FDA anticipates the SBOM to be finished, agreeable with other submission materials, and appropriate to be utilized in the long term and not developed with a submission intent.
Software Component Support Information
Besides a listing of components, the manufacturers have to include details regarding the support of the components.
This includes:
- The status of the support of each component, e.g. it is actively supported, or not supported anymore.
- The end-of-support date, where applicable
Support information aids the FDA in determining the long-term cybersecurity risk, particularly of those components which they might become susceptible to a lack of maintenance.
Software Component Vulnerability Assessment
The other major pillar is the evaluation of the vulnerabilities that come with SBOM elements.
Manufacturers are expected to:
- Detects known vulnerabilities of the components listed.
- Describe vulnerability discovery.
- Appraise the possible effect of the vulnerabilities on the device and system.
- Characterize controls or mitigation measures.
Notably, the FDA never asks devices to be impeccable in every aspect. Instead, the manufacturers have to be capable of providing a security posture which can be reasonably justified.
Ongoing Cybersecurity Processes
Lastly, FDA seeks to find evidence that SBOMs have been supported by continuous cybersecurity practices.
This includes:
- Monitoring processes of the recently revealed vulnerabilities.
- Remediation and patching procedures.
- Vulnerability information communication mechanisms with customers and stakeholders.
These pillars combined show that the SBOM is a component of an active cybersecurity program, and not a fixed compliance document.
FDA Expectations for SBOM Structure and Format
In addition to the fact that the SBOM is necessary in principle, the FDA has put clear expectations on the way an SBOM should be organized and presented. The mentioned expectations are aimed at making sure that SBOMs can be utilized, remain consistent, and meaningful to the assessment of cybersecurity risks.
Machine Readable Format
FDA anticipates SBOMs to be produced and delivered in a machine-readable form. This enables it to be analyzed automatically and be more readily integrated with vulnerability management tools.
The most popular formats are:
- SPDX
- CycloneDX
Completing one of these formats can aid in making sure that there is conformity with the federal guidance, and the review process is less frictional.
Alignment With NTIA Minimum Elements
The minimum elements provided by the U.S. National Telecommunications and Information Administration are in line with the FDA SBOM requirements. Consequently, SBOMs are supposed to have common data items that aid traceability and analysis.
You can refer to the official Minimum Elements for a Software Bill of Materials (SBOM) for details.
SBOMs must include at least:
- Name of suppliers or manufacturers.
- Software component name
- Version information
- Unique identifiers, package URLs or CPEs.
- Dependency Relation between components.
- SBOM author information
- Timestamp of the time of SBOM creation.
These aspects enable reviewers to get to know not only what software is in place, but also how the components interrelate with each other.
Accuracy and Consistency Expectations
It is not sufficient to have a structure. The FDA also checks the accuracy of SBOM with the software that is represented in other parts of the submission.
Reviewers may look for:
- Correlation between the SBOM and software architecture documentation.
- SBOM component vulnerability assessment alignment.
- Proof that the SBOM is the last or released software build.
Wrappers in documents may create doubts and postpone the review.
Software Component Support Information
Besides enumerating software components, FDA SBOM standards require manufacturers to describe how such components are maintained over time. The information assists the FDA in evaluating the ability of a device to be safely maintained during its intended lifetime.
What Is Component Support Information
The information about the component support explains the condition of the individual software components incorporated in the SBOM. This information is used by FDA to review long-term cybersecurity risk, especially when the components are no longer updated or fixed.
The manufacturers are expected to generally provide:
- The existing support of the components.
- The last date of support, should there be one.
This is expected of any software component, both commercial and open-source software.
Common Support Status Categories
The status of support is usually defined in terms of:
- Active maintenance where a component will be regularly updated and security patches installed.
- Not in use as it is no longer maintained, and updates are not given to the component.
- Forsaken, without any encouragement or news.
Such differences assist the reviewers in the speed at which a manufacturer is able to act upon a vulnerability being found.
Challenges With Open-Source Support Information
An open-source component may be more challenging to provide support information because formal support statements are not always present. In such instances, manufacturers might be forced to make an assumption of support status based on:
- Recent commit or release history.
- Patterns of community maintenance.
- Project update frequency
In case the information provided cannot be established to be in support, the FDA anticipates that the manufacturers present the reason and justify the same.
How Support Information Is Submitted
Support information may be:
- Integrated into the SBOM file.
- It is provided as an independent supporting document.
The two methods are both valid, provided the information is well correlated with the SBOM elements and is not difficult to observe.
Vulnerability Assessment Linked to the SBOM
One of the key aspects of FDA SBOM specifications is to illustrate that SBOM data is actively utilized to evaluate and control cybersecurity vulnerabilities. The FDA does not believe that software will be vulnerability-free. It, in its turn, asks manufacturers to know the vulnerabilities that are, how they impact the device, and what controls are in place.
Identifying Known Vulnerabilities
Manufacturers should find out known vulnerabilities that impact the software components inside the SBOM. This usually comprises vulnerabilities that have been revealed via external sources and within the organization.
Key expectations include:
- Providing a list of vulnerabilities related to SBOM components known.
- Mention of popular sources of vulnerabilities.
- Checking that methods of vulnerability identification are documented.
The FDA determines the robustness and repeatability of the methods applied in the discovery of vulnerabilities.
Explaining How Vulnerabilities Were Discovered
In addition to enumerating the vulnerabilities, the manufacturers are supposed to explain the method applied in discovering the vulnerabilities. This is a background that allows reviewers to know the consistency of the assessment process.
Examples of legitimate explanations are:
- An automated vulnerability scanning tool was used.
- Observation of the databases on social vulnerability.
- Intrusion check or scan.
This fact favors the trust that the vulnerabilities will be identified in future.
Evaluating Device and System Impact
Regarding each of the vulnerabilities found, the manufacturers must determine the possible impact on the device and the systems.
This analysis usually covers:
- Exploitability of the vulnerability with the particular configuration of a device.
- The possible impact on the functionality of the device or patient safety.
- The possible exploitation with current controls.
Not everyone is equally dangerous, and the FDA assumes that this should not be poorly recorded.
Mitigation and Compensating Controls
In case there are vulnerabilities, the manufacturers should explain how they are handled.
This may include:
- Patches or software updates
- Exploitability mitigation configurations.
- Limiting impact compensating controls.
A device is not in a situation where it has no vulnerabilities at the time of submission; however, manufacturers must be capable of explaining their security posture reasonably.
Professional Vulnerability Assessment and Penetration Testing (VAPT) helps manufacturers prove to the FDA that their security posture is based on real-world testing rather than just theoretical, automated scanning.
Don’t wait for an RTA (Refuse to Accept) notification. Get a Sample VAPT Report now and see how we validate software security for FDA premarket submissions.
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Case Study: Detecting a Hidden Vulnerability in SaMD
- The Scenario: A healthcare technology company was about to file its 510(k) submission for its cloud-connected Software as a Medical Device. They had already conducted their own scans and were satisfied that they were ready for the FDA.
- The Qualysec Deep Dive: We didn’t just perform the usual scans. We also employed the use of the CycloneDX SBOM to uncover the “software within the software,” or the transitive dependencies. We were able to uncover an undiscovered critical vulnerability in an obscure library that was being employed for the processing of diagnostic data.
- The Attack Proof: With the use of SBOM-based VAPT, we were able to successfully execute an RCE. This would have meant that if the manufacturer were to be the target of an attack, the hacker could potentially manipulate the diagnostic data or exfiltrate sensitive patient data during the syncing of the cloud.
- The Result: The manufacturer was able to avoid the costly “Refuse to Accept” (RTA) ruling by the FDA. Instead, they were able to successfully file their VEX report and prove to the FDA that their device was fully secure.
SBOMs and FDA Post-Market Cybersecurity Expectations
The FDA SBOM requirements are not to cease when a medical device is approved. Although the FDA does not have another post-market SBOM submission requirement, it anticipates manufacturers to maintain the use of SBOMs to facilitate ongoing cybersecurity stewardship.
SBOMs as a Post-Market Tool
SBOMs are also important after a device is introduced in the market to assist the manufacturers in addressing the vulnerabilities revealed. A precise and current SBOM can allow one to easily identify whether a device is vulnerable in case new security problems arise.
On the side of the FDA, SBOMs support:
- Quicker detection of the devices and programs that are affected.
- Better risk analysis based on actual device settings.
- Early remedial and communication actions.
Vulnerability Disclosure and Response
Manufacturers will also have to report the pertinent vulnerabilities and respond to them promptly. SBOMs can simplify this process because they clearly demonstrate which components exist and the way of using them.
The post-market expectations usually involve:
- Tracking of newly reported vulnerabilities of SBOM elements.
- Determining the exploitability of the deployed device.
- Making fixes or mitigation where necessary.
- Providing information on vulnerability to customers and stakeholders.
Importance of Maintaining Updated SBOMs
An aged SBOM makes it less valuable in the post-market cybersecurity. Because software changes are documented as patches, updates or configuration changes, the SBOM is supposed to represent the current state of the device.
Kept SBOMs assist manufacturers:
- Eliminate time wastage in responding to vulnerability queries.
- Be more transparent in cases where vulnerabilities cannot be exploited.
- Encourage internal and external communication.
Regulatory and Market Expectations
Besides regulatory concerns, the use of SBOMs in procurement and risk management procedures is being demanded by healthcare organizations more and more. U.S. Food and Drug Administration to keep track of cybersecurity trends and cast doubts in case new vulnerabilities are seen to impact approved devices.
These expectations taken collectively support one thing. SBOMs are not just a premarket requirement. They play a vital role in accountable post-market cybersecurity of medical equipment.
Common Challenges With FDA SBOM Compliance
Although the idea of an SBOM is simple, a significant number of medical device manufacturers struggle to keep up with the FDA requirements to comply with SBOM requirements on a regular basis. Such difficulties are usually caused by the fact that modern software has many complexities, and one has to be very accurate over time.
Maintaining SBOM Accuracy Over Time
Maintaining SBOMs is one of the most widespread problems. Depending on patches, upgrades, and dependency updates, software components are frequently changed.
Challenges include:
- Monitoring software developments among various groups of developers.
- Having SBOMs that are reflective of the end-deployed device.
- Keeping SBOMs up-to-date with changes in software.
SBOMs can easily become obsolete without a pronounced ownership and a procedure.
Managing Complex Dependency Chains
This is frequently the case in modern medical device software, where open-source integration is used, and the dependency in question is often extensive and deep.
The common challenges are:
- Determining transitive dependencies.
- Knowing the interactivity of dependencies within the device.
- Evaluating risk in the case of the vulnerability of the indirect components.
The vulnerability assessment may have gaps because of incomplete dependency tracking.
Version Control and Traceability
One other challenge is the ability to align SBOM data with the version control and regulatory documentation.
Manufacturers can have difficulties with:
- Mapping components of SBOM to particular software versions.
- Guaranteeing congruency between SBOMs, software documentation and risk evaluation.
- Tracing product lineage in review or inspection by the FDA.
Such inconsistencies may be questioned in the process of premarket evaluation or post-market evaluation.
Resource and Process Maturity Gaps
SBOMs take time, tools and processes to create and maintain. This can be very difficult for organizations whose software development practices are not so mature.
Typical gaps include:
- Poor automation of SBOM generation.
- Non-electronic data collection and updates.
- Absence of defined oversight and ownership of SBOM.
The unresolved SBOM issues are likely to amplify the threat of submission delays, further FDA inquiries, and post-market compliance complaints. Early action on them would assist manufacturers in shifting their basic compliance to a more defensible and sustainable cybersecurity position.
Practical Steps to Prepare for FDA SBOM Compliance in 2026
To be ready to meet the requirements of FDA SBOM in 2026, it is not sufficient to prepare an SBOM at the time of submission. The FDA is placing more and more expectations on SBOMs to be correct, repeatable, and a part of routine development and security procedures. The steps given below define a pragmatic, compliance-based methodology.
Establish Software Inventory Early in Development
Preparation in SBOM must not begin at the end of the regulatory process, but in the design and development.
Key actions include:
- Determining all the software that is in the device, whether third-party software or open-source software.
- Recording dependencies as they come up.
- Inventory must be based on real build artefacts, and not design assumptions.
Early visibility minimizes the last-minute gaps in preparing the submission.
Automate SBOM Generation Where Possible
There is a problem of manual SBOM creation, which is hard to scale and contains errors. Given the changing software, automation can assist in keeping the accuracy in check.
Best practices include:
- Creation of SBOMs directly based on build or source repositories.
- Presentation in machine-readable form in line with FDA requirements.
- Facilitating the consistency of the generation of SBOMs with new updates.
Automation facilitates premarket and post-market demands.
Connect SBOMs to Vulnerability Management
The value of an SBOM would not be much when it is not coupled with vulnerability monitoring.
Manufacturers should:
- Identify impacted components with the help of SBOM data in case new vulnerabilities are released.
- Record the process of determining the exploitability of the device configuration.
- Follow-up decision-making and schedule of remediation.
Such a connection proves the fact that SBOMs are actively involved in risk management.
Define Internal Ownership and Governance
It is important to have clear ownership to ensure the quality of SBOM in the long run.
This typically includes:
- Delegating the accuracy and updates of the SBOM.
- Setting up review and approval processes.
- Setting up development tracks of high-risk vulnerabilities.
Governance makes sure that SBOMs do not lose their credibility over time.
Prepare for FDA Review and Inspection Scenarios
SBOMs can be assessed in the premarket assessment or consulted in the post-market investigations.
Manufacturers are supposed to be prepared to:
- Discuss SBOMs generation and maintenance.
- Demonstrate congruence between SBOMs and other cybersecurity reports.
- Show the use of SBOMs in continued monitoring and reaction.
Those companies that manage SBOMs in the context of regular development and cybersecurity measures are in a better position to stand in the year 2026. Such a strategy eases regulatory burdens, increases response times, and facilitates the sustainability of the devices as opposed to the success of submissions in the short term.
How Qualysec Supports FDA SBOM Readiness
The process of meeting the FDA SBOM requirements does not simply involve the creation of SBOM files. Manufacturers will be anticipated to show that SBOM data is proactively utilized to determine the risks, evaluate vulnerabilities, and facilitate the continued decisions on cybersecurity. Special cybersecurity assessment and monitoring assistance can be used here.
Supporting SBOM-Driven Vulnerability Assessment
Qualysec assists organizations in leveraging the SBOM data as an input to their security testing and risk analysis processes, as opposed to considering it fixed documentation.
This includes:
- Determining these vulnerabilities that can impact the components listed in SBOM.
- Determining the exploitability of known vulnerabilities to the device.
- Making evidence-based, risk-based justification and mitigation decisions.
This practice complies with the FDA’s expectations of actionable vulnerability assessment.
Alignment With Secure Product Development Practices
The requirements of FDA SBOM are interconnected with the more general secure development expectations and risk management expectations. Qualysec assists in achieving the following objectives by assisting manufacturers:
- Consider security posture at development and premarket.
- Determine any gaps that may lead to questioning in an FDA audit.
- Enforce documentation to prove maturity in cybersecurity.
This will minimize the chances of submission delays associated with incomprehensible or vague cybersecurity evidence.
Post-Market Cybersecurity Support
SBOMs remain relevant to vulnerability monitoring and response after a device is already on the market. Qualysec assists in the post-market work by:
- Performing periodical security testing to determine the emergent risks.
- Favoring reassessment in case of software components or settings alteration.
- Assisting in writing up remediation and mitigation measures.
Such actions are complementary to SBOM maintenance and help to sustain regulatory requirements.
Regulatory and Audit Readiness
The FDA reviews and inspections can be directed at the operationality and repeatability of cybersecurity processes. Qualysec supports the manufacturers by:
- Giving reports of assessment to support cybersecurity claims.
- Mapping the results against the FDA cybersecurity terms and requirements.
- Assisting organizations to be ready against regulatory investigations on software risk.
Talk to our Cybersecurity Expert to discuss your specific needs and how we can help your business.
Conclusion
FDA SBOM has become the fundamental component of the medical device cybersecurity compliance. By 2026, the expectation is clear. SBOMs should be precise, maintained, and utilized to control software risk during the lifecycle of the devices.
Manufacturers making SBOMs living artefacts receive more than regulatory acceptance. They enhance both the awareness of vulnerabilities and quicker reaction to new threats, and minimise post-market risk. It is also a method of reducing submission delays and enhancing confidence with the regulators and healthcare providers.
Qualysec assists medical device makers in IPS DX, going beyond simple SBOM development into practical, audit-compliant cybersecurity. Qualysec facilitates compliance that becomes scalable, based on SBOM-enabled vulnerability testing, all the way to post-market testing.
Whether you are preparing to submit to the FDA or enhance your SBOM and vulnerability management strategy, it is high time to design a defensible and future-ready strategy.
Schedule a Consultation with Qualysec today to ensure your medical device meets all FDA cybersecurity requirements.
FAQs
Q: Which medical devices require an FDA SBOM?
A: Some devices are considered cyber devices, and they need to have SBOMs. This covers Software as a Medical Device, and connected medical devices, as well as those devices with embedded or third-party software that may be exposed to cybersecurity risks.
Q: What SBOM formats does the FDA accept?
A: FDA anticipates that SBOMs should be computer-readable and in line with the generally accepted standards. The widely recognized ones are SPDX and CycloneDX.
Q: What information must be included in an FDA-compliant SBOM?
A: An SBOM that meets the requirements of FDA must contain names of software components, version numbers, suppliers, and identifiers, dependency relationships, author details, and a timestamp. It has to include commercial software, open-source, and off-the-shelf software.
Q: Do SBOMs need to be updated after FDA approval?
A: Yes. Although no specific post-market submission is required to submit an SBOM, manufacturers should update SBOMs on a regular basis to assist in monitoring vulnerabilities, disclosure, and remediation throughout the lifecycle of the specific device.
Q: Are manufacturers required to fix all vulnerabilities before submission?
A: No. The FDA does not make it mandatory devices to be completely free of vulnerabilities. The manufacturers have to determine the vulnerabilities known, their impact, and reasonably explain their security posture through mitigations or compensating controls.
Q: How does an SBOM help with ongoing FDA compliance?
An SBOM can assist manufacturers in rapidly deciding whether a device is impacted by vulnerabilities that have been reported, respond to them in time, and demonstrate that cybersecurity risks are managed continuously throughout FDA inspection or post-market investigations.
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