US FDA Cybersecurity Premarket Guidance (2023)

The US FDA Cybersecurity Premarket Guidance (2023) represents a fundamental shift in how medical device manufacturers must approach security throughout the product lifecycle. This regulatory framework establishes mandatory cybersecurity requirements for medical devices before they can enter the US market, requiring manufacturers to demonstrate robust risk management processes and secure product design principles from the earliest stages of development. For DevSecOps leaders and security directors working in medical device development or supporting healthcare technology organizations, understanding the US FDA Cybersecurity Premarket Guidance (2023) isn't just about regulatory compliance—it's about embedding security practices that protect patient safety while maintaining operational efficiency across software development lifecycles.

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What is US FDA Cybersecurity Premarket Guidance (2023)?

The US FDA Cybersecurity Premarket Guidance (2023) is a comprehensive regulatory document issued by the Food and Drug Administration that establishes cybersecurity expectations for medical device manufacturers during the premarket submission process. Released as an update to previous guidance documents, this framework outlines specific requirements that manufacturers must fulfill before receiving FDA clearance or approval for devices containing software or network connectivity.

At its core, this guidance requires manufacturers to submit a cybersecurity plan as part of their premarket submission. This plan must demonstrate how the manufacturer has designed security into the device architecture, how they'll manage vulnerabilities throughout the product's lifecycle, and how they'll provide transparency to healthcare delivery organizations about security risks and capabilities.

The guidance applies to medical devices submitted under 510(k), De Novo, and Premarket Approval (PMA) pathways that contain software or can connect to networks. This covers an extensive range of products—from insulin pumps and pacemakers to hospital network infrastructure and diagnostic imaging systems. The scope intentionally captures both traditional embedded medical devices and increasingly complex software-as-a-medical-device (SaMD) products that rely on cloud infrastructure and continuous deployment models.

Key Components of the Premarket Cybersecurity Guidance

The guidance framework establishes several core components that manufacturers must address:

• Secure Product Design and Development: Manufacturers must demonstrate they've followed secure development practices, including threat modeling, secure coding standards, and security testing throughout development cycles
• Software Bill of Materials (SBOM): Submissions must include comprehensive documentation of software components, including third-party and open-source libraries
• Vulnerability Management: Clear processes for identifying, assessing, and remediating security vulnerabilities post-market
• Transparency and Communication: Mechanisms for coordinating vulnerability disclosure and communicating security updates to users
• Security Architecture Documentation: Detailed description of security controls, authentication mechanisms, encryption implementations, and network security boundaries

What distinguishes this guidance from previous FDA cybersecurity recommendations is its mandatory nature and specificity. Earlier documents provided recommendations that manufacturers could interpret flexibly. The 2023 guidance establishes clear expectations with specific deliverables required in premarket submissions, making cybersecurity a gating requirement for market access rather than a post-market consideration.

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Definition of Medical Device Cybersecurity Risk Management

Cybersecurity risk management in the medical device context refers to the systematic process of identifying, analyzing, evaluating, and treating security risks that could compromise device functionality, data integrity, or patient safety. Unlike traditional product risk management that focuses primarily on physical hazards or functional failures, cybersecurity risk management addresses threats from malicious actors, unintentional misconfigurations, and systemic vulnerabilities in software supply chains.

The FDA's approach aligns with established risk management frameworks like ISO 14971 (medical device risk management) but extends these principles to address cyber-specific threats. This means manufacturers must consider attack scenarios including unauthorized access to device functions, manipulation of therapeutic outputs, exfiltration of protected health information, and denial-of-service conditions that could render devices unavailable during critical care moments.

Risk Management Throughout the Device Lifecycle

The premarket guidance emphasizes that cybersecurity isn't a one-time assessment completed during initial development. Risk management must continue throughout the entire product lifecycle, from initial concept through design, manufacturing, distribution, clinical use, and eventual decommissioning. This lifecycle approach requires manufacturers to establish processes that can adapt to emerging threats—a particularly challenging requirement given that medical devices often remain in clinical use for 10-15 years or longer.

For DevSecOps teams, this creates a fundamental challenge: traditional medical device development cycles measured in years must now incorporate security practices designed for continuously evolving threat landscapes. The guidance effectively requires manufacturers to implement practices common in modern software development—continuous monitoring, rapid patching capabilities, and security telemetry—while maintaining the safety validation and documentation rigor expected in regulated medical products.

Explanation of Software Bill of Materials (SBOM) Requirements

One of the most significant technical requirements in the US FDA Cybersecurity Premarket Guidance (2023) is the Software Bill of Materials mandate. An SBOM is a comprehensive inventory of all software components within a medical device, including commercial software, open-source libraries, firmware, operating system components, and any third-party code dependencies.

The SBOM requirement addresses a critical visibility gap in medical device security. Modern medical devices typically incorporate dozens or hundreds of third-party software components, each with its own vulnerability profile and update cadence. When security researchers discover vulnerabilities in widely-used libraries—like the Log4Shell vulnerability that affected millions of systems—healthcare organizations need to quickly identify which medical devices in their inventory might be affected. Without an SBOM, this assessment becomes a time-consuming manual process involving multiple vendor inquiries and potentially leaving vulnerable systems in clinical use during the investigation.

SBOM Format and Content Standards

The FDA guidance references established SBOM standards including Software Package Data Exchange (SPDX) and CycloneDX formats. These machine-readable formats enable automated vulnerability scanning and supply chain analysis. A compliant SBOM must include:

• Component names: Clear identification of each software component
• Version information: Specific versions or build numbers for each component
• Supplier information: Origin of each component (commercial vendor, open-source project, internally developed)
• Dependency relationships: How components relate to each other within the device architecture
• License information: Software licensing details for compliance verification
• Component hashes: Cryptographic signatures for integrity verification

For organizations building medical devices, generating and maintaining accurate SBOMs requires integration into the software development lifecycle from the beginning. This typically means implementing dependency tracking tools within build pipelines, establishing governance processes for approving third-party components, and creating mechanisms to update SBOMs when components change during maintenance releases.

The software supply chain security implications extend beyond compliance documentation. Organizations that implement robust SBOM practices gain operational benefits including faster vulnerability response, clearer licensing compliance, and better architectural visibility across product portfolios.

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How to Implement Secure Development Practices for FDA Compliance

Meeting the US FDA Cybersecurity Premarket Guidance (2023) requirements demands fundamental changes to how many medical device manufacturers approach software development. The guidance expects manufacturers to demonstrate they've integrated security throughout the development process rather than treating it as a final testing phase before market submission.

Establishing a Secure Development Lifecycle

A secure development lifecycle (SDL) provides the foundational framework for meeting FDA cybersecurity expectations. This approach integrates security activities into each phase of product development:

Requirements Phase: Security requirements must be defined alongside functional requirements. This includes identifying critical assets (patient data, therapeutic control parameters, authentication credentials), defining security boundaries between system components, and establishing acceptable risk thresholds. Threat modeling should begin during this phase, identifying potential attack surfaces and adversary motivations relevant to the specific device type.

Design Phase: Security architecture decisions made during design have lasting impact on a device's security posture. The guidance expects manufacturers to apply security design principles including defense in depth (multiple layers of security controls), least privilege (components have only the permissions they require), and secure defaults (devices ship in secure configurations without requiring user customization). Design documentation submitted to FDA should demonstrate these principles through architecture diagrams, data flow models, and security control descriptions.

Implementation Phase: Secure coding practices become critical during actual development. This includes following coding standards that prevent common vulnerabilities, conducting code reviews with security focus, and using static analysis tools to identify potential security flaws. For teams accustomed to traditional embedded device development, this may require training on modern application security concepts and tools.

Verification and Validation Phase: Security testing must go beyond functional validation. The guidance expects manufacturers to conduct penetration testing, vulnerability scanning, and fuzzing to identify security weaknesses before submission. Testing should address both known vulnerability patterns (using frameworks like OWASP Top 10 or CWE Top 25) and device-specific security requirements identified during threat modeling.

Integrating DevSecOps Practices in Regulated Environments

DevSecOps practices offer a pathway to meeting FDA cybersecurity requirements while maintaining development velocity. Automation becomes particularly valuable given the documentation and evidence requirements for regulatory submissions:

• Automated security scanning: Integrating static application security testing (SAST) and software composition analysis (SCA) tools into CI/CD pipelines provides continuous security assessment and creates audit trails demonstrating security diligence
• Infrastructure as code: Defining infrastructure configurations in version-controlled code creates reproducible, auditable deployment environments that simplify security validation
• Container security: For devices using containerized architectures, implementing container scanning and runtime security monitoring addresses vulnerabilities in base images and runtime dependencies
• Secrets management: Proper handling of API keys, certificates, and credentials through dedicated secrets management tools prevents exposure in source code or configuration files

Organizations building modern software-as-a-medical-device products face the challenge of reconciling continuous deployment practices with FDA validation requirements. The guidance acknowledges this tension by accepting a controlled deployment model where security updates can be deployed without requiring new premarket submissions, provided the manufacturer has established appropriate change control processes and demonstrated the security update doesn't introduce new safety risks.

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Understanding Vulnerability Management and Coordinated Disclosure

The US FDA Cybersecurity Premarket Guidance (2023) places considerable emphasis on how manufacturers will manage vulnerabilities discovered after a device reaches the market. This post-market cybersecurity posture is now evaluated during the premarket submission process, requiring manufacturers to demonstrate mature vulnerability management capabilities before receiving clearance.

Components of an Effective Vulnerability Management Program

A comprehensive vulnerability management program addresses the complete lifecycle of security weaknesses from discovery through remediation:

Monitoring and Detection: Manufacturers must establish mechanisms to become aware of vulnerabilities affecting their devices. This includes monitoring security advisories for third-party components (which the SBOM makes possible), engaging with security research community, and implementing security telemetry that might indicate exploitation attempts in deployed devices. Subscribing to vulnerability databases like the National Vulnerability Database (NVD) and vendor-specific security mailing lists provides early warning of issues affecting device components.

Assessment and Triage: When a potential vulnerability is identified, manufacturers must assess whether it actually affects their device and what the potential patient safety impact might be. Not every vulnerability in a component creates patient risk—the assessment must consider how the device actually uses the vulnerable component and whether the device architecture includes compensating controls that mitigate the vulnerability. This assessment informs prioritization decisions about which vulnerabilities require immediate attention versus which can be addressed in routine maintenance releases.

Remediation Development: Creating fixes for identified vulnerabilities requires the same rigor as original development. Patches must be tested to verify they actually resolve the vulnerability without introducing new functional or security issues. For devices in clinical use, manufacturers must consider deployment logistics—can devices be updated remotely, or do they require on-site service visits? The remediation timeline must balance the urgency of the security risk against the practical realities of updating medical devices in clinical environments.

Deployment and Communication: The guidance expects manufacturers to have clear processes for deploying security updates and communicating security information to healthcare delivery organizations. This includes technical patch notes that security teams can use to assess urgency, deployment instructions that biomedical engineering teams can follow, and patient safety information that clinical risk managers need to make informed decisions about vulnerability remediation timelines.

Coordinated Vulnerability Disclosure Programs

The FDA guidance strongly encourages manufacturers to establish coordinated vulnerability disclosure (CVD) programs that provide security researchers a clear process for reporting potential security issues. This approach recognizes that external security researchers play a valuable role in identifying vulnerabilities that internal testing might miss.

A mature CVD program includes several elements:

• A public security contact (typically a security@company email address) that researchers can use to report findings
• A published disclosure policy explaining how the manufacturer will handle reports, expected response timelines, and coordination expectations
• A secure communication channel for exchanging technical vulnerability details
• A timeline for acknowledging reports, providing assessment outcomes, and coordinating public disclosure
• Recognition mechanisms that credit researchers for their contributions (where researchers desire credit)

Organizations implementing CVD programs must balance transparency with patient safety considerations. Premature disclosure of a critical vulnerability before mitigations are available could create patient risk, while delayed disclosure prevents healthcare organizations from making informed risk management decisions. The guidance supports coordinated disclosure timelines that give manufacturers reasonable opportunity to develop and deploy fixes before public disclosure, typically 90-180 days depending on vulnerability severity.

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Security Architecture Documentation and Transparency Requirements

The premarket submission requirements include detailed security architecture documentation that explains to FDA reviewers how security controls protect device functionality and patient data. This documentation serves dual purposes: it demonstrates to regulators that appropriate security controls exist, and it provides transparency to healthcare delivery organizations about device security capabilities and limitations.

Essential Elements of Security Architecture Documentation

Effective security architecture documentation submitted with premarket applications should address:

Authentication and Authorization: How does the device verify user identity? What authentication factors are supported (passwords, biometrics, smart cards, multi-factor authentication)? How does the device enforce role-based access controls to ensure users can only access functions appropriate to their clinical roles? For devices that communicate with other systems, how are system-to-system authentication mechanisms implemented?

Data Protection: What data does the device collect, store, and transmit? How is sensitive data protected at rest and in transit? What encryption algorithms and key management practices are used? How long is data retained, and what mechanisms exist for secure data deletion? These questions become particularly complex for devices that synchronize data to cloud services or integrate with electronic health record systems.

Network Security: For network-connected devices, what network services are exposed? What protocols are supported, and are there known vulnerabilities in those protocol implementations? How does the device handle network segmentation and isolation? Can the device operate in network environments with restrictive firewall policies? Many healthcare delivery organizations implement strict network segmentation as a compensating control for vulnerable medical devices, so understanding a device's network requirements is critical for deployment planning.

Secure Update Mechanisms: How are software updates authenticated to prevent installation of malicious firmware? What rollback capabilities exist if an update causes problems? Can updates be deployed without taking the device offline during critical patient care? The update mechanism itself represents a significant attack surface that requires careful security design.

Audit Logging and Monitoring: What security-relevant events are logged? How long are logs retained, and how are they protected from tampering? Can logs be exported to centralized security information and event management (SIEM) systems? Robust audit logging capabilities enable healthcare organizations to detect potential security incidents and conduct forensic investigations when suspicious activity occurs.

Creating Transparency for Healthcare Delivery Organizations

Beyond meeting FDA submission requirements, security architecture documentation increasingly serves as a communication tool with healthcare customers. Organizations like the American Hospital Association and ECRI have advocated for manufacturer transparency about device security capabilities, arguing that healthcare delivery organizations need this information to make informed procurement decisions and implement appropriate network security controls.

Leading device manufacturers now publish security white papers or product security fact sheets that provide detailed security information without compromising proprietary implementation details. These documents help healthcare security teams understand device security posture, evaluate how devices fit within their security architecture, and identify compensating controls that might be needed to address device limitations.

For manufacturers accustomed to treating security details as confidential, this transparency requirement represents a cultural shift. The FDA guidance recognizes this tension and doesn't require public disclosure of information that could be exploited by attackers. The focus is on providing enough transparency that healthcare organizations can make informed risk decisions without creating a roadmap for adversaries.

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Legacy Device Challenges and Modernization Strategies

While the US FDA Cybersecurity Premarket Guidance (2023) applies to new device submissions, it creates ripple effects across manufacturers' existing product portfolios. Healthcare delivery organizations increasingly expect similar security capabilities in devices they already own, creating market pressure for manufacturers to retrofit security capabilities into legacy products.

Legacy medical devices present particular challenges. Many were designed before cybersecurity became a central concern, using outdated operating systems, unsupported software libraries, and network protocols with known vulnerabilities. The devices may lack fundamental security capabilities like encrypted communications or user authentication. Manufacturers face difficult decisions about whether to invest in updating these older platforms or focus resources on new products that meet current standards.

Approaches to Managing Legacy Device Risk

Several strategies help manage security risks in legacy device populations:

Network Segmentation: Isolating legacy devices on separate network segments with strict access controls limits the potential impact of vulnerabilities. This approach requires careful planning to ensure necessary communications for clinical workflows remain possible while blocking lateral movement paths that attackers might exploit.

Compensating Controls: When devices can't be updated to address vulnerabilities, external security controls can provide risk reduction. Network intrusion detection systems, application firewalls, and privileged access management systems can monitor device traffic and limit exposure even when the device itself has security weaknesses.

Selective Upgrades: For critical devices that will remain in use for years, manufacturers may develop security upgrade packages that retrofit modern capabilities without requiring complete device replacement. This might include updating operating systems, replacing vulnerable components, or adding hardware security modules for cryptographic operations.

Lifecycle Planning: Healthcare organizations increasingly factor device security into lifecycle replacement decisions. Devices approaching end-of-support from their manufacturers represent growing security risks and may need accelerated replacement even if functionally adequate.

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Third-Party Software Components and Open Source Security

Modern medical devices heavily rely on third-party and open-source software components. A typical device might include an operating system (often a variant of Linux or a real-time OS), networking libraries, cryptographic implementations, user interface frameworks, and numerous smaller utility libraries. The SBOM requirement exists precisely because this software supply chain complexity creates vulnerability management challenges.

Open Source Security Considerations

Open-source software provides tremendous value to medical device manufacturers—proven libraries, community security review, and avoidance of licensing costs. Yet open-source components also introduce supply chain risks. Projects vary widely in their security maturity, some have active maintainer communities while others are effectively abandoned, and licensing obligations require careful management.

The FDA guidance doesn't prohibit open-source software use, but it does require manufacturers to demonstrate they understand what open-source components their devices contain and have processes to manage vulnerabilities in those components. This means:

• Maintaining an accurate inventory of open-source components (via the SBOM)
• Evaluating the security posture of open-source projects before incorporating them
• Monitoring security advisories for components in use
• Having processes to update or replace components when vulnerabilities are discovered
• Understanding and complying with open-source license obligations

Organizations building medical devices benefit from implementing open source security practices that provide visibility into their software supply chain and enable rapid response when vulnerabilities emerge in dependencies.

Commercial Third-Party Software Challenges

Commercial third-party components present different challenges. Vendors may be reluctant to disclose detailed component information, making SBOM generation difficult. License terms might restrict security testing. Update timelines may not align with the device manufacturer's needs—a critical security patch from a component vendor might arrive when the device manufacturer isn't planning a maintenance release.

Device manufacturers must establish clear contractual terms with software suppliers that address security responsibilities. This includes requirements for security testing, vulnerability disclosure obligations, update timelines, and SBOM information sharing. For critical components, manufacturers should evaluate vendors' security practices and potentially require security assessments before integration.

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Cloud-Connected Devices and Infrastructure Security

Medical devices increasingly leverage cloud infrastructure for data storage, analytics, remote monitoring, and over-the-air updates. This connectivity enables valuable clinical capabilities but expands the security scope beyond the device itself to include cloud infrastructure, APIs, and data transmission paths.

The US FDA Cybersecurity Premarket Guidance (2023) addresses cloud-connected devices by expecting manufacturers to describe the complete system architecture including cloud components. This means security documentation must cover:

• How devices authenticate to cloud services
• What data is transmitted to the cloud and how it's protected in transit
• How cloud infrastructure is secured and maintained
• What happens if cloud connectivity is lost—does the device remain functional?
• How software updates are delivered and authenticated
• What third-party cloud service providers are used and what security responsibilities they assume

For manufacturers using cloud platforms like AWS, Azure, or Google Cloud, the shared responsibility model becomes relevant. The cloud provider secures the underlying infrastructure, but the manufacturer remains responsible for securing their applications, configuring services properly, managing access controls, and protecting patient data.

API Security for Connected Medical Devices

Application programming interfaces (APIs) that enable communication between devices and cloud services represent critical attack surfaces. API security requires attention to authentication, authorization, input validation, rate limiting, and monitoring. Many API security vulnerabilities arise from implementation flaws rather than design issues—failing to properly validate inputs, exposing excessive data in responses, or using weak authentication mechanisms.

Organizations building cloud-connected medical devices should implement API security best practices including API gateways for centralized security enforcement, authentication standards like OAuth 2.0 or mutual TLS, and comprehensive API testing to identify security flaws before deployment. The security blog provides insights into modern API security approaches applicable to medical device development.

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Organizational Capabilities and Resource Requirements

Meeting the US FDA Cybersecurity Premarket Guidance (2023) requirements demands organizational capabilities that extend beyond technical implementation. Manufacturers need appropriate expertise, processes, and resources to sustain cybersecurity throughout product lifecycles.

Building Security Expertise

Medical device manufacturers traditionally employed expertise in mechanical engineering, electrical engineering, and regulatory affairs. The cybersecurity guidance effectively mandates adding security engineering expertise to product development teams. This includes professionals with skills in threat modeling, secure development practices, penetration testing, vulnerability management, and incident response.

For smaller manufacturers without existing security teams, this creates a capability gap. Options include hiring security professionals, contracting with security consulting firms, or implementing security training programs for existing engineers. The challenge is that medical device security requires both cybersecurity expertise and understanding of medical device regulatory requirements—a combination not commonly found in the workforce.

Process Integration and Quality Management

Medical device manufacturers already operate under quality management system requirements (FDA Quality System Regulation and ISO 13485). Cybersecurity processes must integrate with existing quality management frameworks. This means documenting security activities in quality management systems, subjecting security-related changes to design controls, and including cybersecurity in risk management processes.

The integration can be challenging because cybersecurity often requires faster response cycles than traditional medical device change control processes allow. When a critical vulnerability is discovered, waiting weeks or months for change control approval may not be acceptable from a patient safety perspective. Manufacturers must develop streamlined change control pathways for security updates while maintaining appropriate risk assessment and validation.

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Global Regulatory Harmonization and International Standards

While the US FDA Cybersecurity Premarket Guidance (2023) applies specifically to the US market, similar regulatory expectations are emerging globally. The European Union's Medical Device Regulation (MDR) includes cybersecurity requirements, though with less prescriptive implementation guidance than the FDA provides. The International Medical Device Regulators Forum (IMDRF) has published guidance documents on medical device cybersecurity with the goal of harmonizing regulatory expectations across jurisdictions.

For manufacturers selling devices internationally, navigating varying cybersecurity requirements across markets creates complexity. Building to the most stringent requirements (generally the FDA guidance) provides a foundation that typically satisfies other markets' expectations as well. The SBOM requirement, for example, isn't explicitly mandated in all jurisdictions but provides value for vulnerability management regardless of regulatory requirements.

Relevant Standards and Frameworks

Several technical standards provide implementation guidance for meeting regulatory cybersecurity expectations:

• IEC 62443: Originally developed for industrial control systems, this series of standards addresses security for operational technology and is increasingly referenced for medical device security
• AAMI TIR57: Provides principles for medical device security risk management
• UL 2900: Series of standards for software cybersecurity in medical devices and other products
• ISO/IEC 27001: Information security management system standard applicable to manufacturers' internal security practices
• NIST Cybersecurity Framework: Provides a risk-based approach to cybersecurity applicable to medical device manufacturers

The FDA guidance doesn't mandate any specific standard but references several as examples of acceptable approaches. Manufacturers benefit from adopting recognized standards both for technical implementation guidance and as evidence of following industry best practices in regulatory submissions.

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Economic and Market Implications

The US FDA Cybersecurity Premarket Guidance (2023) creates economic implications for both manufacturers and healthcare delivery organizations. For manufacturers, implementing the required security capabilities represents significant investment in engineering resources, security tools, and ongoing vulnerability management operations. These costs ultimately flow into device pricing, potentially making medical devices more expensive.

Yet the guidance also creates market opportunities. Manufacturers that develop mature security capabilities can differentiate themselves in procurement processes. Healthcare organizations increasingly evaluate device security as a purchasing criterion, and devices with strong security postures may command market preference even at higher price points.

For healthcare delivery organizations, the guidance should eventually reduce the security burden. Devices entering the market with appropriate security capabilities require less compensating control implementation and create less vulnerability management workload. The SBOM requirement enables faster vulnerability assessment when security issues emerge, reducing the staff time required to evaluate device risk.

Impact on Innovation and Time to Market

A common concern about increased regulatory requirements is their potential impact on innovation and time to market. Adding security requirements to the premarket submission process could theoretically delay device availability. The FDA has sought to mitigate this by providing clear guidance about expectations, reducing ambiguity that might cause submission delays due to requests for additional information.

Organizations that integrate security throughout development rather than treating it as a pre-submission activity typically find less impact on time to market. Security issues discovered late in development create delays, while security practices integrated from project initiation become part of normal development rhythms. This is a key principle of DevSecOps—shifting security left in the development lifecycle to find and fix issues when they're less costly to address.

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Preparing Your Organization for FDA Cybersecurity Requirements

For DevSecOps leaders and security directors supporting medical device development, preparing for the US FDA Cybersecurity Premarket Guidance (2023) requires strategic planning across people, processes, and technology dimensions.

Assessment and Gap Analysis

Begin by assessing current capabilities against the guidance requirements. This gap analysis should evaluate:

• Do current development processes include security activities at each lifecycle phase?
• Can the organization generate accurate SBOMs for its devices?
• Does vulnerability management infrastructure exist to monitor, assess, and respond to security issues?
• Are security architecture documentation practices adequate for regulatory submissions?
• Do quality management systems include appropriate security process documentation?

The gap analysis identifies priority areas for investment and process development. Organizations should expect to find gaps—the guidance represents a significant increase in security expectations compared to previous FDA requirements.

Tooling and Infrastructure Investment

Meeting the guidance requirements efficiently requires appropriate tooling. Key infrastructure components include:

Software Composition Analysis (SCA) tools that automatically identify third-party components in codebases and generate SBOMs. These tools integrate with build pipelines to maintain up-to-date component inventories and alert when vulnerable components are detected.

Static Application Security Testing (SAST) tools that analyze source code for security vulnerabilities. These tools find common coding errors that create security weaknesses like buffer overflows, SQL injection points, or authentication bypasses.

Dynamic Application Security Testing (DAST) tools that test running applications for vulnerabilities. DAST tools simulate attacker techniques to identify security flaws that might not be apparent in source code review.

Container scanning tools for organizations using containerized architectures. These tools identify vulnerabilities in container images and ensure containers follow security best practices.

Secrets management systems that securely store and manage cryptographic keys, API credentials, and other secrets, preventing hardcoded credentials in source code.

Vulnerability management platforms that aggregate vulnerability data from multiple sources, track remediation status, and prioritize security work based on risk.

Organizations should evaluate tools based on their integration capabilities with existing development environments, accuracy of findings, and ability to generate evidence suitable for regulatory submissions. The security solutions available today provide various approaches to these capabilities.

Training and Skill Development

Building organizational security capability requires investing in people development. Engineering teams need training on secure coding practices, security testing techniques, and threat modeling approaches. Regulatory affairs professionals need understanding of cybersecurity concepts to effectively communicate device security posture in submissions. Quality assurance teams need expertise to validate security controls and assess security-related changes.

Training programs should be tailored to different roles. Developers need hands-on secure coding training with examples relevant to medical device contexts. Architects need threat modeling and security design pattern education. Testing teams need penetration testing and security assessment training. Cross-functional security training helps build shared understanding and breaks down silos between development, quality, and regulatory functions.

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Working with FDA During the Premarket Review Process

Submitting a device for FDA review under the new cybersecurity guidance requires thoughtful preparation. The premarket submission should present a coherent narrative about how security is integrated into the device design and how the manufacturer will manage security throughout the product lifecycle.

Documentation Best Practices

Effective cybersecurity documentation for FDA submissions should be:

• Comprehensive yet concise: Cover all required elements without excessive length that obscures key information
• Technically detailed: Provide specific implementation details that demonstrate actual security controls rather than generic security assertions
• Risk-focused: Clearly link security controls to identified risks, showing how design decisions address potential threats
• Lifecycle-oriented: Address not just initial design but ongoing security maintenance

The submission should anticipate reviewer questions. Common areas where FDA reviewers request additional information include authentication mechanisms, encryption implementations, update processes, and vulnerability management procedures. Proactively addressing these topics in initial submissions can reduce review cycle time.

Pre-Submission Meetings

The FDA offers pre-submission meetings where manufacturers can discuss regulatory strategy before formal submission. For devices with novel security challenges or complex system architectures, these meetings provide valuable opportunity to align with FDA expectations early in development. Manufacturers can present their proposed security approach and receive feedback about whether it adequately addresses FDA's concerns.

Pre-submission meetings are particularly valuable for first-time submissions under the new guidance, helping manufacturers understand how FDA interprets the requirements and what level of detail reviewers expect.

Continuous Improvement and Staying Current

Cybersecurity is not a static discipline. Threat landscapes evolve, new vulnerabilities emerge, and security best practices mature over time. Organizations must treat cybersecurity as a continuous improvement journey rather than a one-time compliance exercise.

Staying current requires ongoing engagement with the security community. Participating in information sharing organizations like the Health Information Sharing and Analysis Center (H-ISAC) provides early warning of threats targeting healthcare. Following security research publications and conference presentations reveals emerging attack techniques. Monitoring regulatory communications from FDA and other agencies ensures awareness of evolving expectations.

Organizations should periodically reassess their security posture, conducting regular threat model updates, security architecture reviews, and penetration testing to identify areas for improvement. As security tools and practices mature, manufacturers may find opportunities to enhance security capabilities in existing products through updates.

The medical device industry is transitioning toward a security maturity model where cybersecurity becomes deeply integrated into product development culture. Organizations that embrace this transition position themselves for long-term success in an increasingly security-conscious market.

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Partner with Security Experts to Accelerate FDA Compliance

Navigating the US FDA Cybersecurity Premarket Guidance (2023) requirements doesn't have to be a journey you take alone. The complexity of modern software supply chains, the specialized expertise required for security architecture documentation, and the operational demands of continuous vulnerability management can strain even well-resourced organizations. Whether you're preparing your first submission under the new guidance or looking to streamline security practices across your medical device portfolio, having the right tools and expertise makes a significant difference in both compliance outcomes and time to market.

KUSARI provides software supply chain security solutions specifically designed for organizations building complex, regulated products. From automated SBOM generation to vulnerability tracking and secure development pipeline integration, Kusari helps DevSecOps teams implement the security capabilities FDA expects while maintaining development velocity. Schedule a demo to see how Kusari can support your FDA cybersecurity compliance journey.

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How Does the FDA Cybersecurity Premarket Guidance Affect Software Updates After Market Approval?

The US FDA Cybersecurity Premarket Guidance (2023) creates a framework for how manufacturers manage software updates after a device reaches the market. The FDA Cybersecurity Premarket Guidance distinguishes between routine security updates and changes that would require a new premarket submission. Security patches that address identified vulnerabilities without changing device functionality typically don't require new 510(k) submissions, provided the manufacturer has documented appropriate change control processes and can demonstrate the security update doesn't introduce new safety risks.

The guidance expects manufacturers to establish update mechanisms during initial development that enable timely security patch deployment. This means devices should have the technical capability to receive updates—whether through over-the-air mechanisms, removable media, or service connections—and these update mechanisms themselves must be secure to prevent installation of malicious software. The premarket submission should describe the planned update process, including how updates are authenticated, tested, and validated before deployment.

For security updates, the FDA has indicated through various guidance documents that manufacturers should implement a risk-based approach. Critical vulnerabilities that create immediate patient safety concerns should be addressed quickly, potentially within days or weeks. Lower-severity vulnerabilities might be bundled into planned maintenance releases. The key is having a documented process that healthcare organizations can rely on for timely security maintenance throughout the device lifecycle.

What Is Required in a Software Bill of Materials for FDA Submissions?

A Software Bill of Materials (SBOM) for FDA submissions under the US FDA Cybersecurity Premarket Guidance (2023) must provide comprehensive transparency into all software components within a medical device. The FDA Cybersecurity Premarket Guidance requires SBOMs to follow established formats like SPDX or CycloneDX that enable machine readability and automated vulnerability scanning. At minimum, the SBOM must identify each software component by name, specify the version or release number, identify the component supplier or source, and document dependencies between components.

The SBOM requirement applies to all software layers within the device including the operating system, middleware, application code, firmware, and any libraries or frameworks. Both commercial software and open-source components must be documented. For nested dependencies—where component A depends on component B which depends on component C—the SBOM should ideally capture these relationships to provide complete visibility into the software supply chain.

The depth of SBOM detail should enable healthcare organizations to quickly determine if their devices are affected when vulnerabilities are publicly disclosed. When a security advisory announces a vulnerability in a specific library version, a properly constructed SBOM allows immediate identification of affected devices without requiring extensive reverse engineering or vendor inquiries. This transparency serves patient safety by enabling faster risk assessment and remediation planning when security issues emerge.

How Do Small Medical Device Manufacturers Comply With the New Cybersecurity Requirements?

Small medical device manufacturers face unique challenges with the US FDA Cybersecurity Premarket Guidance (2023) due to limited resources and specialized expertise. The FDA Cybersecurity Premarket Guidance applies equally to all manufacturers regardless of size, but smaller organizations can take strategic approaches to meet requirements efficiently. Focusing on risk-based security decisions helps small manufacturers prioritize investments where they provide the most patient safety benefit rather than trying to implement every possible security control.

For small manufacturers, leveraging existing frameworks and tools provides an efficient path to compliance. Using established secure development standards like OWASP guidance for web applications or CWE mitigation techniques for common vulnerabilities provides proven security approaches without requiring internal development of security frameworks. Commercial security tools, while representing an investment, typically cost less than building equivalent internal capabilities and provide vendor support that compensates for limited internal expertise.

Partnerships and outsourcing can help small manufacturers access expertise they can't maintain full-time. Working with security consulting firms for activities like penetration testing, threat modeling, or security architecture review provides access to specialized skills on a project basis. Some manufacturers form consortiums or industry working groups to share security best practices and potentially pool resources for common security challenges. The key is recognizing that cybersecurity has become a cost of doing business in medical device development and planning accordingly in product development budgets and timelines.

What Happens If a Device Already on the Market Doesn't Meet the New Guidance?

Devices that received FDA clearance or approval before the US FDA Cybersecurity Premarket Guidance (2023) took effect are not immediately required to meet the new standards. The FDA Cybersecurity Premarket Guidance applies to new premarket submissions, meaning it affects devices under active development or modifications to existing devices that require new regulatory submissions. Legacy devices that are already legally marketed continue under their existing regulatory status.

That said, manufacturers have ongoing post-market obligations to address cybersecurity risks that could affect patient safety, regardless of when a device was originally cleared. If a security vulnerability is discovered in a marketed device that creates patient risk, the manufacturer is expected to address it through updates, customer notifications, or other risk mitigation approaches. The FDA can issue safety communications or, in severe cases, require recalls if manufacturers don't adequately address known cybersecurity risks in marketed devices.

Many manufacturers are voluntarily applying the new cybersecurity guidance principles to legacy products where feasible. This might include creating SBOMs for devices already on the market, implementing vulnerability management processes that cover both new and existing products, and deploying security updates to address identified risks. While not strictly required for devices cleared before the guidance took effect, these practices position manufacturers well for long-term market success as customers increasingly expect consistent security standards across product portfolios. The US FDA Cybersecurity Premarket Guidance (2023) fundamentaly changes the medical device security landscape by making robust cybersecurity practices a requirement for market access rather than an optional consideration.