FDA Software Licensing: Impact on Medical Devices

If you make, buy, or review a connected medical device, software licensing now affects FDA clearance, patch rights, and device support.

Here’s the short version: since March 29, 2023, FDA has required cybersecurity details for cyber devices in premarket submissions. And as of June 27, 2025, FDA’s final guidance says machine-readable SBOMs are required for cyber devices. That means you need a clear record of each software part, who supplied it, its version, its license, and when support ends.

If I had to boil the article down to a few points, it would be this:

• Licensing is no longer just a legal task. It can block patching, updates, and software fixes.
• SBOMs now matter at submission and after launch. FDA can reject cyber-device submissions that lack the required cybersecurity details.
• Third-party software is the hard part. Open-source, commercial code, firmware, SDKs, middleware, and transitive dependencies all need tracking.
• Supplier contracts need plain terms. You need rights for fixes, SBOM updates, vulnerability notices, and support that fits a device life that may last 10 to 15 years.
• The safest path is simple: check license terms before choosing software, keep SBOMs current in every build, and tie supplier review to your QMS.

A few facts stand out. The article points to FDA’s authority under Section 524B of the FD&C Act. It also notes that devices can stay in use for a decade or more, which makes end-of-support dates a big issue. And when an SBOM is incomplete, the result can be delays, extra FDA questions, or a failed submission screen.

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So if you’re thinking, “Is software licensing now part of device risk management?” the answer is yes. The article’s core message is simple: software rights, SBOM quality, and supplier control now sit in the same FDA risk bucket.

1. The FDA Problem: Third-Party Software, Licensing, and Cyber Device Obligations

FDA's cybersecurity framework turned software accountability into a compliance requirement. Starting March 29, 2023, premarket submissions for cyber devices must include cybersecurity information. This isn't just a paperwork step. It's a quality and safety duty that runs across the full device lifecycle. As a result, license review has to happen during component selection, not later as a legal cleanup task.

How FDA Guidance Expands Software Accountability

FDA expects inventories to cover a lot more than the obvious pieces. That includes firmware, operating systems, SDKs, middleware, drivers, network stacks, cloud services, companion apps, and transitive dependencies.^[6][13] SOUP should also be treated as part of the inventory and monitored for vulnerabilities.^[10][11]

Put simply, if software touches the device, FDA wants visibility into it.

FDA is also building cybersecurity into the Quality Management System, which makes software transparency and supplier risk management core safety controls.^[1][7] That visibility shapes how the SBOM must be built and maintained.

Why Licensing Terms Are Now an Operational Risk

Licensing terms now affect supplier oversight, not just procurement. They become an operational risk when postmarket patching runs into license limits.^[8][5] If a license restricts modification, reverse engineering, disclosure, or redistribution, it can get in the way of FDA-required vulnerability response.^[12][4][14]

A no-reverse-engineering clause can stop root-cause analysis. Copyleft terms can complicate emergency patch distribution. So licensing isn't a side issue anymore. It's part of the evidence needed to show cybersecurity control.

2. How SBOM and Documentation Requirements Change Software Licensing Decisions

What FDA Expects in Software Inventories

FDA's updated final guidance, issued June 27, 2025, makes machine-readable SBOMs mandatory for cyber devices and strongly recommended for all other software-containing medical devices.^[20][21] The legal basis is Section 524B(b)(3) of the FD&C Act, added by the Consolidated Appropriations Act of 2023.^[19]

FDA points to the NTIA Minimum Elements and machine-readable formats like SPDX, CycloneDX, and SWID, usually delivered as JSON or XML.^[9][22] In plain terms, these formats make software inventories easier to search, review, and check. That matters when a team needs to spot license conflicts, expired support, or unapproved components before they turn into a bigger mess.

Each SBOM entry should include the supplier name, component name and version, unique identifiers such as CPE or package URL, dependency relationships, license type and license text reference, provenance, and end-of-support (EOS) dates.^[15][17][22] The EOS field deserves extra attention. If a component is close to EOS and there's no documented upgrade path, The risk isn't limited to cybersecurity. It can also hit product lifecycle planning hard, especially for devices that may stay in service for 10 to 15 years or more.

How Better SBOM Governance Changes Development Outcomes

Before SBOM rules took center stage, licensing often ran on habit and convenience. A developer might pull in an open-source library because it solved the problem, while no one stopped to check copyleft duties or whether the support timeline matched the device's expected market life. SBOM documentation changes that. It puts those choices in front of engineering, regulatory affairs, procurement, and supplier management.^[16][17][18]

The gap between a disciplined SBOM process and ad hoc component use shows up in day-to-day work, not just in policy documents:

This isn't just an operations issue. It's a regulatory one too. When teams treat the SBOM as a living artifact and update it with every build or component change, they can react to new CVEs much faster and show FDA reviewers a current, defensible view of what's inside the device. When they don't, they often end up piecing together component histories under pressure during submissions or postmarket incidents.

3. Where Licensing Creates Risk in Device Development and Vendor Relationships

Once SBOMs show what's inside a device, licensing decides what a team can actually do with those parts over time.

Regulatory and Lifecycle Risks

Weak licensing governance tends to show up during FDA review and then again after the device is in the field. Incomplete SBOMs, missing license terms, or undocumented support status can lead to AI requests or RTAs and slow clearance.^[2][3] That can set a 510(k), De Novo, or PMA review back by weeks or even months while teams rush to sort out license agreements or swap out components that fall short.

The lifecycle side is just as serious. If support ends before the device reaches its planned service life, manufacturers are left with a bad set of options: redesign the product, keep using unsupported software, or cut service commitments short. None of those choices is easy, and all of them add patient, business, and regulatory risk.^[25][27]

There’s another problem here too. Vendors may change license terms, fees, or cloud requirements after deployment, and those changes can clash with existing network controls. And if a component’s license blocks redistribution of modified binaries, a manufacturer may not be able to push a patch to devices already in use. That’s a tough spot to be in when a security fix is needed fast.

These risks grow when vendors control the terms tied to patching, updating, or disclosing components.

Contract and Supplier Oversight Pressure

FDA expectations reach beyond the manufacturer and into the supplier base, including contract developers. That means SBOM delivery and vulnerability notice need to be enforceable duties, not handshake deals.^[26][28][24] Contracts should spell out a few things clearly:

• Updated SBOMs
• Timely notice of vulnerabilities
• Patch support that matches the device’s service life
• Clear redistribution rights for fixes

If those terms aren’t written into the contract, supplier oversight programs have little power during an audit or inspection.

Licensing also shapes buyer trust. Incomplete SBOMs can slow HDO reviews and make them less favorable. They can also lead to longer security reviews or even removal from preferred vendor lists. By contrast, clear SBOM sharing and clear license rights help HDO reviews move faster and cut down on security questionnaire back-and-forth.

Better licensing and SBOM governance lowers regulatory, lifecycle, vendor, and postmarket risk at the same time.

The practical move is to build licensing checks and supplier obligations into QMS-controlled sourcing and change management.

4. Practical Solutions: Align Licensing, SBOMs, and Supplier Controls with FDA Expectations

Licensing review, SBOM control, and supplier oversight should sit inside one workflow, not three separate tracks. The main checkpoints are component selection, SBOM upkeep, and vendor monitoring.

Build Licensing Review into Component Selection and QMS Processes

Licensing review needs to start when teams pick a component. Under 21 CFR 820.30, design controls must verify that the manufacturer has the right to patch, modify, and distribute fixes without breaking license terms or vendor support. In plain English: if a zero-day hits, the company needs to know it can patch the component without stepping outside the license. That makes licensing a design input, not a cleanup task for legal after the fact.

Procurement workflows should treat these checks as a hard gate. Under 21 CFR 820.50, supplier controls require documented vendor qualification. That review should confirm that the vendor can provide a machine-readable SBOM and commit to vulnerability disclosure. If a license blocks disclosure of component names or versions, it runs into FDA SBOM expectations for cyber devices and should be treated as a disqualifying issue. Putting these checks into purchasing SOPs and design review checklists helps teams apply the same standard every time and leaves a clear audit trail.

Treat the SBOM as a Living Control, Not a One-Time Artifact

Generate machine-readable SBOMs in CI/CD with CycloneDX or SPDX. Then keep them current with each build. The SBOM should feed vulnerability monitoring, support-status tracking, and change control.

That matters for a simple reason: a current SBOM makes CVE impact analysis and patch decisions much faster. It also supports Section 524B postmarket vulnerability management and cuts RTA risk. The same inventory should also feed vendor review and change control, so teams aren't working from different records.

Use Structured Third-Party Risk Workflows for Continuous Oversight

Structured risk workflows help manufacturers track vendor evidence, watch for security changes, and reassess suppliers on a continuous basis. That's a big shift from one-time reviews, which often age out fast and leave blind spots in postmarket oversight.

Censinet RiskOps™ (censinet.com) is built for this in healthcare. It enables HDOs and vendors to streamline third-party and enterprise risk assessments, centralize security evidence, benchmark cybersecurity posture against industry standards, and manage risk across teams.

The table below maps each practice area to its FDA guidance alignment and the teams that own execution:

Conclusion: Make Software Licensing Part of Medical Device Risk Management

FDA cybersecurity guidance now treats software licensing, SBOM quality, supplier accountability, and vendor contracts as lifecycle controls, not back-office tasks. That shift matters. These controls help protect patient safety, support market access, and shape whether a device can be patched, supported, and kept on the market. Put simply, this isn’t just about paperwork. It’s about whether software rights, SBOMs, and supplier commitments actually work together across the life of the device.

A device with incomplete SBOM data or unverified licensing terms carries hidden risk. And that risk tends to show up at the worst possible moment, like during a vulnerability response, a regulatory submission, or postmarket surveillance. Since Oct. 1, 2023, FDA can refuse cyber-device submissions that lack required cybersecurity or SBOM information, which makes licensing visibility and SBOM completeness direct gatekeepers for market access.^[23][30][3]

That leaves four actions that matter most.

Key Takeaways for Healthcare and Device Leaders

Verify software rights before component selection, not after. Check usage, modification, and redistribution rights early, especially for open-source, dual-licensed, and embedded components. If you wait, restrictive terms can turn into a serious blocker when a vulnerability appears.

Keep SBOMs accurate and connected. A one-time SBOM created for submission has limited value over time. Reviews from the field show that SBOM tools still miss component relationships, versions, and supplier names.^[29] That gap has to be handled through governance, with SBOM updates tied to every build, patch, and component change.

Require stronger supplier documentation upfront. Contracts should spell out vulnerability disclosure, patch support, EOS dates, and escalation contacts. When suppliers can’t meet those terms, the risk doesn’t stay small. It grows across the device lifecycle.

Build continuous oversight, not periodic reviews. License terms change. Vendors get acquired. Components hit end-of-support. Censinet RiskOps™ helps healthcare organizations manage third-party vendor risk management and enterprise risk assessments, cybersecurity benchmarking, and collaborative risk management. Continuous third-party risk monitoring helps teams spot license, supplier, and support changes before they turn into regulatory or patient-safety problems.

Organizations that handle this well treat licensing and SBOMs as operational controls. That’s how software licensing becomes part of medical device risk management.

FAQs

Does this apply to all medical devices or only cyber devices?

No. The FDA's cybersecurity regulations apply only to cyber devices, not every medical device.

Here’s the simple version: a cyber device is a medical device that includes sponsor-validated, installed, or authorized software and can connect to the internet or another network. It also needs to have features that could be open to cybersecurity threats.

That definition also covers devices that can connect to a network, even if network features aren’t turned on right now. So the key point isn’t just whether the device is currently online. It’s whether the device has the software and network connection capability that put it in scope.

What happens if our SBOM is incomplete or out of date?

An incomplete or outdated Software Bill of Materials (SBOM) can create major regulatory and security risks.

For premarket submissions, the FDA may ask for more information. If required data is missing, it may also refuse the submission.

Over a device’s 10–15 year lifecycle, an inaccurate, version-controlled SBOM can slow down vulnerability triage, obscure transitive dependencies, and create audit risk under 21 CFR 820.30(i) and configuration management.

How should we handle software that reaches end of support during a device’s life?

If software hits end of support while a device is still in use, the manufacturer is still on the hook for the risk that comes with it. That risk doesn’t just disappear because vendor support does.

Use compensating controls like network segmentation or access restrictions to reduce exposure while you work on a formal migration or replacement plan. Think of it as putting guardrails in place while you prepare the bigger fix.

Document that plan clearly. Also record any technical reason for accepting residual risk in the device’s risk management file. Proactive tracking of end-of-support dates in the Software Bill of Materials helps make sure these steps are ready before support runs out.

Related Blog Posts

• Why Patch Validation Matters for Medical Devices
• FDA Cybersecurity Labeling: What HDOs Need to Know
• How FDA Rules Impact Supplier Cybersecurity
• FDA Guidance: Securing Third-Party Libraries in Devices