5 Key FDA Cybersecurity Labeling Requirements for Devices
Post Summary
The FDA's 2025 guidance on medical device cybersecurity outlines five essential labeling requirements to enhance security and protect patient safety. These rules apply to devices with software or network connectivity, such as insulin pumps and imaging scanners. Here’s what you need to know:
- Communication Interfaces Disclosure: Manufacturers must list all device interfaces (e.g., USB, Bluetooth), including their purposes, whether enabled, and potential risks.
- Secure Configuration Instructions: Step-by-step guidance for setting up devices securely, including default settings, access management, and physical/logical interface details.
- Software Bill of Materials (SBOM): A detailed inventory of software components, versions, and suppliers to help track vulnerabilities and manage risks.
- Update and Patch Management: Clear procedures for software updates, including how they’re delivered, verified, and tracked.
- Known Vulnerabilities and Residual Risks Disclosure: Transparency about remaining risks, vulnerability reporting, and end-of-support timelines.
These elements ensure healthcare providers can securely install, maintain, and decommission devices while minimizing cybersecurity threats. By aligning with these standards, manufacturers and healthcare organizations can better safeguard medical devices and patient safety.
FDA's 5 Essential Cybersecurity Labeling Requirements for Medical Devices
A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
sbb-itb-535baee
1. Communication Interfaces Disclosure
The FDA mandates that manufacturers disclose all physical and logical interfaces on a medical device, even those that are disabled or unused [1]. This includes everything from USB ports and Ethernet connections to WiFi radios, Bluetooth modules, and diagnostic interfaces embedded in firmware. Each interface must be identified with its purpose clearly stated, along with information on whether it is enabled by default [1]. This level of transparency is essential for conducting thorough risk assessments.
Clarity and Completeness of Required Information
A simple list of ports isn’t enough. Manufacturers are required to provide a detailed "Connection Inventory" that outlines the types of data, code, or commands transmitted through each communication channel [3]. This inventory should include specifics like protocol names, version numbers, ports, channels, and frequencies. Security details, such as authentication methods (including algorithms and key lengths), authorization models (like user roles), and session management processes, must also be documented [3].
Even interfaces not meant for end-user interaction must be disclosed. The FDA highlights this with an example: "Though the USB interface may only be intended for transferring images, the capability for someone to use it outside of its intended purpose remains (i.e., loading malicious software, etc.)... a device with a USB interface is still by definition a cyber device" [3]. Such transparency gives IT administrators a clear understanding of the device's potential vulnerabilities, enabling them to implement measures like network segmentation. These detailed inventories allow healthcare delivery organizations (HDOs) to better secure their networks.
Practicality for Manufacturers and Healthcare Delivery Organizations (HDOs)
To support secure implementation, manufacturers must provide documentation that is both clear and actionable. When interface details are well-documented, HDOs can seamlessly integrate devices into their existing security systems. Visual aids, such as system architecture diagrams showing components, data flows, and trust boundaries, can simplify complex technical information for hospital IT teams [1]. Including handoff sequences between communication paths can further enhance understanding.
Manufacturers must also specify which configurations they are responsible for and which require action from the operator. For example, if a device needs to be placed behind a firewall or requires specific network settings, these instructions must be explicitly stated [1]. Such guidance helps avoid misconfigurations that could leave devices vulnerable to unauthorized access.
HDOs can use these disclosures to strengthen their cybersecurity strategies. Platforms like Censinet RiskOps™ can help incorporate this information into broader risk management frameworks, improving overall security.
Impact on Patient Safety and Device Security
For networked devices, detailed interface disclosures play a critical role in reducing the risk of widespread harm. A single exploit could potentially compromise multiple devices, putting patient safety at risk [3]. By equipping IT administrators with comprehensive information about communication pathways, manufacturers enable better security monitoring and ensure devices maintain their performance during cybersecurity incidents. This proactive approach helps protect patients from harm caused by unauthorized access or tampering, reinforcing the connection between cybersecurity measures and patient safety.
2. Secure Configuration and Hardening Instructions
The FDA mandates that manufacturers provide detailed, step-by-step guidance for securely setting up and hardening medical devices. This isn’t just about offering a standard installation manual. Instead, it includes prerequisites like specific operating system versions, network protocols, and user permissions. It also explains the device's secure default settings and the reasoning behind them[1]. After clearly outlining the device interfaces, manufacturers must ensure secure configuration and hardening to protect system integrity.
Clarity and Completeness of Required Information
Hardening instructions should cover five essential areas:
- Secure default configurations: List all default settings and warn users about the risks of altering them.
- Access management: Provide straightforward guidance for managing user access and ensuring secure operation.
- Supporting infrastructure: Detail requirements like network segmentation, firewall placement, or integration with authentication systems such as Active Directory.
- Physical and logical interfaces: Specify which interfaces are enabled by default and indicate whether they can be modified.
- Sanitization procedures: Include clear instructions for data wiping, key revocation, and verification before retiring or reselling a device[1].
Alignment with FDA's 2025 Cybersecurity Guidance
The FDA's 2025 guidance emphasizes labeling as a critical component of the Secure Product Development Framework (SPDF). Starting October 1, 2023, the FDA began issuing "Refuse to Accept" decisions for premarket submissions lacking adequate cybersecurity documentation and labeling. This guidance includes 14 specific elements required in device labeling, with hardening instructions being a central part[1][5].
Practicality for Manufacturers and Healthcare Delivery Organizations (HDOs)
Effective hardening instructions often include visual aids like system architecture diagrams to show where and how security controls function. These tools not only meet FDA requirements but also provide actionable steps for HDOs. The FDA suggests optionally using the NEMA Manufacturer Disclosure Statement for Medical Device Security (MDS2) form to present security controls in a standardized format. To ensure usability, instructions should be written in clear, actionable language, catering to both IT administrators and clinicians. Platforms such as Censinet RiskOps™ can help healthcare organizations integrate these manufacturer-provided guidelines into broader vendor risk assessments and device lifecycle management.
Impact on Patient Safety and Device Security
Clear hardening instructions play a crucial role in preventing unauthorized access or tampering, which could jeopardize patient safety. For instance, in 2021, Fresenius Kabi issued a cybersecurity alert for approximately 1,200 infusion pumps that required both hardware updates and software patches to fix vulnerabilities[4]. By providing detailed guidance on disabling unnecessary interfaces and enforcing secure default settings, manufacturers empower HDO IT teams to maintain device security and functionality, even during cybersecurity incidents. These robust measures strengthen the overall cybersecurity labeling strategy, ensuring devices remain secure and compliant.
3. Software Bill of Materials (SBOM) Summary
A Software Bill of Materials (SBOM) serves as a detailed inventory of all software components, libraries, and dependencies within a medical device. For devices classified by the FDA as "cyber devices" - those with internet connectivity or external ports like USB - an SBOM is now a mandatory requirement for premarket submissions, including 510(k), De Novo, and PMA applications. This mandate became effective on March 29, 2023, under Section 524B of the FD&C Act [6][7]. By listing critical software components, the SBOM builds upon earlier cybersecurity measures to ensure safer device operations.
Clarity and Completeness of Required Information
The FDA specifies that SBOMs must include the NTIA Baseline Attributes, along with additional lifecycle details tailored to medical device security. Key fields include:
- Component name
- Version
- Supplier
- Unique identifier (e.g., PURL or CPE)
- System relationship
- ISO 8601 timestamp
- Cryptographic hash for integrity
The FDA also requires manufacturers to document the Level of Support (whether a component is actively maintained or abandoned) and the End of Support Date (when security updates will stop) [6]. Since these fields aren’t standard in all SBOM formats, manufacturers must submit a supplemental SBOM Support Report with lifecycle information. To avoid unnecessary alerts, development-only dependencies should be excluded. SBOMs typically cover language-level dependencies, system dependencies, and the operating system but exclude external cloud services like AWS S3, as manufacturers don’t control their patching [6].
Alignment with FDA's 2025 Cybersecurity Guidance
The FDA’s 2025 cybersecurity guidance requires SBOMs to be "readily available to the end user at all times", moving beyond older on-request models [6]. In feedback shared in August 2024, an FDA Lead Cybersecurity Specialist stated:
"While we acknowledge you have stated a user is able to request the SBOM via email, this documentation should be readily available to the end user at all times. Please provide the SBOM to the end user as part of the device system labeling." [6]
To meet this requirement, manufacturers are encouraged to create an online portal or repository where up-to-date SBOMs can be accessed continuously. While the FDA doesn’t mandate a specific file format, CycloneDX and SPDX are widely accepted, with CycloneDX often preferred for its emphasis on security. Manufacturers should provide SBOMs in both machine-readable formats (e.g., JSON) and human-readable formats (e.g., PDF or Excel) to accommodate FDA reviewers’ preferences [6]. These guidelines not only clarify expectations but also help manufacturers streamline the integration of SBOMs into their development processes.
Practicality for Manufacturers and Healthcare Delivery Organizations (HDOs)
Incorporating SBOM generation into the CI/CD pipeline ensures that the inventory updates automatically with each software release. This approach allows manufacturers to detect unsupported or vulnerable dependencies early, well before devices are distributed [6]. For Healthcare Delivery Organizations (HDOs), machine-readable SBOMs are indispensable for automating asset management and monitoring vulnerabilities in real time. Tools like Dependency Track, Trivy, or Snyk enable HDOs to continuously scan for known vulnerabilities. Platforms such as Censinet RiskOps™ allow HDOs to integrate SBOM data into broader risk management workflows, streamlining medical device lifecycle management. By linking software components to critical safety functions - like alarm systems or heart rate monitoring - both manufacturers and HDOs can ensure that security efforts focus on components with the greatest impact on patient safety [7].
Impact on Patient Safety and Device Security
A well-maintained SBOM is a cornerstone of effective vulnerability management. It helps identify and track risks in third-party, open-source, and commercial software components that could compromise a device’s integrity [7]. In response to emerging threats, an accurate SBOM allows for swift, targeted action. Organizations can quickly pinpoint affected devices and prioritize patches. The FDA recommends addressing critical vulnerabilities within 24 hours and high-risk vulnerabilities within 72 hours [7].
As noted by sbomgenerator.com:
"The practical value of an SBOM is that it strengthens the cybersecurity story inside a premarket submission. It helps reviewers understand component inventory, third-party software exposure, and how the manufacturer plans to manage vulnerabilities after release." [7]
This level of transparency gives HDOs the insight needed to manage software supply chain risks effectively, safeguarding both network security and patient data throughout the device's lifecycle [7].
4. Update, Patch, and Vulnerability Management Procedures
The FDA's labeling requirements emphasize the importance of documenting how software and firmware updates are distributed, authenticated, and tracked. According to the FDA's 2025 Premarket Cybersecurity Guidance (Section VI.A), manufacturers must clearly differentiate between routine updates and targeted fixes for vulnerabilities. This distinction helps healthcare organizations understand the purpose of each update. Labels should also specify delivery methods (e.g., OTA, USB), update frequency (e.g., quarterly or as needed), and verification methods like digital signatures or encryption [1].
Clarity and Completeness of Required Information
Labels must include essential details like version numbers and rollback prevention measures to stop devices from reverting to less secure states. Manufacturers are also required to identify authorized personnel for managing updates, outline the Coordinated Vulnerability Disclosure (CVD) process for reporting security issues, and provide End-of-Support (EOS) dates [1].
As Velentium Medical explains:
"Cybersecurity labeling is therefore both a regulatory artifact and a safety control." [1]
Alignment with FDA's 2025 Cybersecurity Guidance
The guidance calls for manufacturers to specify how users will be notified about updates, emergency patches, or vulnerability advisories. Notifications can be delivered through secure portals, email alerts, or in-app messages. Clear instructions must also be provided for responding to security alerts and reporting potential incidents to a designated contact. By outlining the roles of manufacturers (providing patches) and healthcare delivery organizations (applying updates and monitoring logs), the labeling process helps close security gaps. This clarity ensures both parties can effectively implement these procedures.
Practicality for Manufacturers and Healthcare Delivery Organizations (HDOs)
Well-structured labels provide IT administrators in healthcare delivery organizations (HDOs) with actionable guidance for integrating devices into their networks. This includes specifying minimum network security measures and patch management expectations. Tools like Censinet RiskOps™ can support HDOs by streamlining update and patch management workflows, tracking devices requiring urgent attention, and ensuring compliance with FDA-recommended timelines [1]. These processes not only simplify operations but also contribute to patient safety.
Impact on Patient Safety and Device Security
Clear update and patch management protocols reduce the risk of unauthorized access or tampering by ensuring devices are securely updated. Maintaining robust version control keeps devices running on the safest software versions. As Aiyanaar notes:
"A transparent label = a safer device - and a more trusted brand." [2]
This transparency builds trust between manufacturers and healthcare organizations, ensuring that security measures protect device functionality even during updates or cybersecurity incidents. By reinforcing the broader cybersecurity labeling framework, these procedures safeguard both device performance and patient safety throughout the entire lifecycle of the device.
5. Known Vulnerabilities and Residual Risks Disclosure
Under the FDA's cybersecurity labeling framework, manufacturers are required to disclose any remaining security gaps, even after implementing protective measures. According to IEC 81001-5-1 5.8.2(d), this means providing a clear statement of residual risks after all security measures have been applied, as well as explaining the potential consequences of changing secure settings.
Clarity and Completeness of Required Information
Labels must include detailed instructions on how users can report suspected security issues through the manufacturer's Coordinated Vulnerability Disclosure (CVD) process. Additionally, manufacturers need to outline how users will be notified about vulnerability advisories and emergency patches. Communicating End-of-Support (EOS) dates is equally critical, as this marks the point when cybersecurity responsibilities shift to the user due to the cessation of security updates.
The FDA also encourages including Vulnerability Exploitability eXchange (VEX) data alongside the Software Bill of Materials (SBOM). This helps healthcare organizations identify which vulnerabilities in third-party components are relevant to the device. These disclosures align with earlier FDA guidelines on interface and update management, ensuring a more comprehensive understanding of device security.
Alignment with FDA's 2025 Cybersecurity Guidance
The FDA's 2025 guidance emphasizes that vulnerability disclosure is both a regulatory requirement under Section 524B of the FD&C Act and a key safety measure within the Secure Product Development Framework. Manufacturers are expected to use a dual-track risk assessment approach, evaluating both clinical safety (as per ISO 14971) and the exploitability of security vulnerabilities. This level of transparency allows healthcare delivery organizations to implement compensatory controls - such as network segmentation or tailored firewall settings - for risks that cannot be eliminated by the device itself.
Practicality for Manufacturers and Healthcare Delivery Organizations (HDOs)
Effective disclosure requires clear, straightforward language that IT administrators and clinicians can easily understand. Instead of relying on technical jargon, manufacturers should provide actionable statements that clearly define the responsibilities of both parties. For example, a label might state that the manufacturer ensures encrypted data transmission using AES-256, while the healthcare delivery organization is responsible for configuring network-level access controls. Tools like Censinet RiskOps™ can assist HDOs in tracking disclosed vulnerabilities across their device inventory and ensuring proper compensatory controls are applied.
Impact on Patient Safety and Device Security
Transparent disclosure of vulnerabilities plays a crucial role in preventing patient harm by enabling healthcare organizations to sustain a device's security posture throughout its lifecycle. Velentium Medical highlights this point:
"When manufacturers communicate security transparently, users are empowered to maintain protection throughout the product's life."
Such openness fosters trust between manufacturers and healthcare organizations, positioning manufacturers as active contributors to patient safety. By clearly outlining both the protections offered and the remaining risks, manufacturers help ensure that essential device functions remain secure, even during cybersecurity events. This approach lays the groundwork for implementing robust cybersecurity labeling practices.
How to Implement FDA Cybersecurity Labeling Requirements
Creating a robust approach to FDA cybersecurity labeling starts with automating the generation of SBOMs (Software Bill of Materials) using machine-readable formats like CycloneDX or SPDX. This ensures a detailed and traceable inventory of software components and open-source libraries, which is critical for quickly addressing vulnerabilities as they arise. Additionally, the NEMA MDS2 Form offers a standardized way to present device security features, making it easier for healthcare delivery organizations (HDOs) to compare security controls across different manufacturers.
Clear and precise technical documentation is another key element. Replace general claims with specific, verifiable details. For example, instead of saying "uses encryption", specify "Encrypts data using AES-256, certified to FIPS 140-3." Similarly, provide actionable details about how updates are delivered. This helps IT administrators in healthcare facilities plan maintenance and security protocols effectively.
Another essential step is establishing a Coordinated Vulnerability Disclosure (CVD) process. This process should outline how users can report issues and how they will receive vulnerability advisories and emergency patches. The FDA's 2025 Premarket Cybersecurity Guidance requires 14 specific elements in device labeling, and compliance with these mandates involves aligning with standards like ISO 14971 for risk management and IEC 81001-5-1:2021 for health software security.
For HDOs managing large networks of devices, tools like Censinet RiskOps™ can simplify the process. These platforms allow organizations to track vulnerabilities across their device inventories, apply appropriate compensatory controls, and use SBOM data to monitor Common Vulnerabilities and Exposures (CVEs) in third-party components. They also facilitate collaboration with manufacturers on patch management and help maintain up-to-date documentation to demonstrate ongoing FDA compliance.
Finally, these measures should integrate into a broader labeling strategy. Use CI/CD pipelines to update labels quickly and provide healthcare organizations with the latest labeling data. This enables real-time risk assessments and network protections, such as segmentation and customized firewall rules, ensuring that cybersecurity measures remain dynamic and effective.
Conclusion
FDA cybersecurity labeling requirements play a crucial role in connecting device design with patient care. As Velentium Medical aptly puts it:
"Cybersecurity labeling connects design intent to real-world device use" [1].
This connection underscores how cybersecurity labeling supports the entire medical device lifecycle, ensuring both functionality and safety.
By adhering to these requirements, manufacturers help maintain device performance and shield patient safety during cybersecurity incidents. The five core elements - communication interfaces, secure configuration instructions, SBOM summaries, update procedures, and vulnerability disclosures - work in unison to establish a clear and actionable framework. This framework empowers healthcare organizations to safeguard their networks and patients effectively, covering devices from installation to eventual decommissioning.
Incorporating labeling requirements early in the design process is key. Using straightforward language and visual aids can demystify complex security configurations for all users. As the industry moves toward machine-readable formats and aligns with international standards like IEC 81001-5-1:2021, automation tools become increasingly important for ensuring accuracy across software updates.
Clear communication fosters transparency, benefiting the entire healthcare system. These practices not only simplify compliance efforts but also strengthen operational security by linking technical guidelines to practical patient care outcomes. When manufacturers provide clear security information, healthcare organizations are better equipped to make informed decisions about deploying devices, segmenting networks, and planning for the device lifecycle. Tools like Censinet RiskOps™ further assist organizations in monitoring vulnerabilities and collaborating with manufacturers for ongoing risk management.
Strong cybersecurity labeling ultimately builds trust and ensures device security throughout its lifecycle. By adopting best practices and leveraging available tools, manufacturers and healthcare providers can work together to protect patient safety and enhance the security of the healthcare delivery system. This collaborative effort strengthens the overall resilience of healthcare networks.
FAQs
What qualifies as an FDA “cyber device”?
Medical devices classified as "cyber devices" by the FDA are those equipped with software, capable of connecting to the internet or other networks (either directly or indirectly), and designed in a way that makes them vulnerable to cybersecurity risks. To maintain their safety and proper functioning, these devices must comply with specific FDA cybersecurity regulations.
How should hospitals access and use an SBOM in practice?
Hospitals should incorporate a Software Bill of Materials (SBOM) into their risk management and device monitoring strategies. An SBOM acts like a detailed ingredient list for a medical device, outlining all its software components, their versions, and any known vulnerabilities. This transparency helps healthcare organizations identify and address potential risks more effectively.
Hospitals can request SBOMs directly from device manufacturers and streamline their management using tools like Censinet RiskOps™, which automates the process. By keeping SBOMs updated regularly, hospitals can stay on top of vulnerabilities and meet FDA requirements for maintaining security throughout a device's lifecycle.
What should we do when a device reaches end-of-support?
When a device reaches the end of its support period, manufacturers must supply clear documentation outlining residual risks, known vulnerabilities, and recommendations for secure configurations. This helps users stay informed, manage potential risks, and implement necessary updates to maintain safety and security.
