Understanding FDA Postmarket Cybersecurity Guidance
Post Summary
The FDA's updated 2025 postmarket cybersecurity guidance highlights the importance of securing medical devices throughout their lifecycle. As connected devices become more common in healthcare, this guidance ensures manufacturers and healthcare organizations address vulnerabilities to protect patient safety.
Key Insights:
- Cybersecurity as Safety: The FDA treats cybersecurity as a core part of device safety, requiring manufacturers to adopt risk models that assess exploitability and impact.
- Stricter Requirements: Manufacturers must document security risk plans, maintain Software Bills of Materials (SBOMs), and conduct ongoing vulnerability monitoring.
- Lifecycle Focus: Threat modeling, penetration testing, and patch management are required throughout a device’s lifecycle, not just during development.
- Healthcare Challenges: Hospitals often face cyberattacks due to outdated systems and limited budgets, making compliance critical for patient safety.
- FDA Enforcement: Submissions that fail to meet cybersecurity standards can now be rejected.
By following these guidelines, organizations can better protect devices, networks, and patients from cybersecurity threats.
FDA Postmarket Cybersecurity Requirements Breakdown
What Qualifies as a 'Cyber Device' Under FDA Rules
The FDA defines a "cyber device" under Section 524B(c) of the FD&C Act based on specific criteria. These criteria determine which devices must comply with postmarket cybersecurity requirements.
A device is considered a cyber device if it meets three conditions:
- It includes software that is validated, installed, or authorized by the sponsor, either as a device or within a device [4].
- It has the capability to connect to the internet [4].
- It contains technological features validated, installed, or authorized by the sponsor that could be exposed to cybersecurity threats [4].
This definition applies to a broad range of connected medical devices. Examples include WiFi-enabled infusion pumps, patient monitoring systems that transmit data over hospital networks, and diagnostic imaging equipment linked to electronic health records. Even software applications running on tablets or computers that connect to the internet fall under this classification.
Importantly, devices with optional connectivity features are not exempt. If a device can connect to the internet, even if it's not actively used, it must meet the cybersecurity requirements.
With this classification in mind, the next focus is on the compliance steps manufacturers need to follow.
Main Postmarket Compliance Requirements
Once a device is classified as a cyber device, manufacturers must implement robust measures to monitor and address cybersecurity risks. This includes continuous monitoring and a coordinated approach to vulnerability disclosure. The FDA mandates that manufacturers develop a plan to identify, assess, and address cybersecurity vulnerabilities throughout the device's lifecycle [1].
A key element of compliance is establishing a coordinated vulnerability disclosure process. Manufacturers need to create systems for receiving, evaluating, and responding to vulnerability reports from researchers, healthcare providers, and other stakeholders. This involves clear communication channels and defined timelines for addressing reported issues.
Another critical requirement is integrating cybersecurity processes into the company’s quality management system. These processes should ensure that devices and related systems remain secure and must be regularly updated to address emerging threats [1].
Patch management also plays a central role in compliance. Manufacturers are required to provide updates and patches to address vulnerabilities. The FDA specifies two types of patching schedules:
- Regular updates for known vulnerabilities on a justified schedule [5].
- Immediate out-of-cycle patches for critical vulnerabilities that could lead to uncontrolled risks [5].
For instance, a recent advisory from CISA regarding vulnerabilities in the Fresenius Kabi Agilia Connect Infusion System highlighted the importance of timely patching.
Documentation and Reporting Requirements
In addition to managing vulnerabilities, manufacturers must maintain thorough documentation and adhere to structured reporting protocols to stay compliant.
One essential documentation requirement is the Software Bill of Materials (SBOM). This document lists all software components, including commercial, open-source, and off-the-shelf elements [1]. An SBOM helps healthcare organizations and regulators quickly identify affected devices when vulnerabilities are discovered in third-party software.
The 2025 FDA guidance emphasizes documentation that matches the cybersecurity risk level of the device [7]. Key documents include:
- Cybersecurity risk assessment and management plans
- Threat modeling analyses
- Evidence of Secure Product Development Framework (SPDF) implementation
- SBOMs
- Vulnerability monitoring and management plans
- Penetration testing reports
- Security architecture documentation
Comprehensive adverse event reporting is also required. The FDA annually processes over two million medical device reports related to deaths, injuries, or malfunctions [8]. Reporting requirements vary by stakeholder:
| Reporter | What to Report | Form # | Recipient | Timeline |
|---|---|---|---|---|
| Manufacturers | Deaths, serious injuries, malfunctions | Form FDA 3500A | FDA | Within 30 calendar days |
| Manufacturers | FDA-designated events or remedial actions | Form FDA 3500A | FDA | Within 5 work days |
| Importers | Deaths, serious injuries | Form FDA 3500A | FDA and manufacturer | Within 30 calendar days |
| Importers | Malfunctions | Form FDA 3500A | Manufacturer | Within 30 calendar days |
| User Facility | Device-related deaths | Form FDA 3500A | FDA and manufacturer | Within 10 work days |
| User Facility | Device-related serious injuries | Form FDA 3500A | Manufacturer (or FDA if unknown) | Within 10 work days |
| User Facility | Annual death and serious injury summaries | Form FDA 3419 | FDA | January 1 for the preceding year |
Healthcare organizations must also establish incident response plans that align with CISA reporting timelines [7]. These plans should include systems to quickly generate required reports during cybersecurity incidents.
For organizations managing numerous devices and vendors, platforms like Censinet RiskOps™ can simplify compliance. Such tools streamline risk assessments, benchmark cybersecurity efforts, and centralize documentation for medical devices, supply chains, and clinical applications.
"The definition of a medical device encompasses not only capital equipment, but also surgical instruments, patient monitoring, and even software. The breadth and variety of the field, combined with the critical importance of med devices to life and safety, requires a deliberate, focused approach to cybersecurity to ensure that they are resilient throughout their lifecycle." - Nancy Brainerd (CISSP/CIPP), Senior Director of Product Security [7]
Building Risk Management into Device Lifecycle Processes
Risk Management Best Practices
Managing cybersecurity risks for medical IoT devices demands a thorough, lifecycle-focused approach. Start by incorporating threat modeling during the design phase to pinpoint vulnerabilities before the product takes its final shape.
From there, implement robust authentication measures as your first line of defense. Multi-factor authentication (MFA) should be mandatory at all access points to prevent breaches caused by weak credentials. Add layers of protection through network segmentation and real-time intrusion detection systems, which help contain potential damage.
Secure all data during transmission with end-to-end encryption and establish clear protocols for regular updates and emergency patches. This ensures vulnerabilities are addressed promptly.
Vendor risk management is equally important. Healthcare organizations must carefully evaluate the security practices of IoT device manufacturers and suppliers. This includes assessing their cybersecurity protocols, incident response capabilities, and commitment to providing ongoing security updates throughout the device lifecycle.
Finally, align these practices with established industry standards to ensure compliance and comprehensive protection.
Aligning Risk Management with Standards and Regulations
To ensure both security and compliance, operational practices must align with global standards. A key standard to consider is ISO 14971, which defines risk as the combination of the likelihood of harm and its severity. The FDA also emphasizes risk-based processes during device reviews and inspections, highlighting the importance of integrating cybersecurity into quality management systems from the very beginning.
Other critical standards include IEC 60601, IEC 62366, ISO 10993, and ISO 13485, which require manufacturers to address cybersecurity risks as part of their overall risk management strategy. Additionally, ANSI AAMI SW96:2023 provides specific guidance for managing security risks in medical devices, stating:
"Provides requirements and guidance when addressing design, production and post‐production security risk management for medical devices within the risk management framework defined by ISO 14971."
A newer standard, IEC 81001-5-1, focuses on medical devices and health IT software. It mandates security integration throughout the software development lifecycle, including independent vulnerability and penetration testing. Healthcare organizations are encouraged to adopt this standard proactively to stay ahead of regulatory changes. As Joe Dawson, Principal Software Security Analyst at Intertek Connected World, explains:
"IEC 81001-5-1 is not a distant future requirement – it is a rapidly expanding global standard that manufacturers must prepare for today."
Executive leadership also plays a critical role in determining acceptable product risks and ensuring cybersecurity remains a priority at all organizational levels. Comprehensive documentation - such as risk assessments, compliance records, and justifications for any deviations from standard requirements - is essential to demonstrate that security measures have been implemented and maintained effectively.
Using Platforms for Collaborative Risk Management
Managing the risks associated with connected medical devices can be incredibly complex, especially for organizations overseeing hundreds or even thousands of devices from multiple vendors. Centralized platforms can simplify this complexity by streamlining risk assessments, consolidating documentation, and enabling collaboration across teams.
Censinet RiskOps™ is one such platform tailored for the healthcare sector. It offers tools for third-party and enterprise risk assessments, cybersecurity benchmarking, and collaborative risk management. By fostering better collaboration between healthcare delivery organizations and device manufacturers, it reinforces the shared responsibility for security.
The platform also automates workflows to keep compliance documentation up-to-date and ensure timely risk management activities. Its command center provides real-time insights into an organization’s cybersecurity posture, helping executives and risk teams make informed decisions about risk mitigation and acceptance.
Additionally, Censinet AI™ enhances third-party risk assessments by automating processes like completing security questionnaires, summarizing vendor documentation, and generating detailed risk reports. This approach allows risk teams to scale their operations without sacrificing oversight, making it easier to manage security testing, vulnerability assessments, and compliance records efficiently. By combining AI with human expertise, organizations can streamline their risk management efforts while maintaining control over critical decisions.
How to Achieve and Maintain FDA Postmarket Compliance
Setting Up Vulnerability Management and Patching Protocols
Building a strong vulnerability management system is a cornerstone of staying compliant with FDA postmarket requirements. Manufacturers are expected to create and submit a detailed plan explaining how they will monitor, identify, and address cybersecurity vulnerabilities and exploits in their medical devices [9]. This is not a one-and-done task - it demands an ongoing, systematic approach.
Start with continuous monitoring. Use vulnerability databases, threat intelligence feeds, and input from security researchers to keep an eye on potential threats. The FDA requires manufacturers to provide timely updates and patches to protect device security and patient safety [9]. This involves having a clear, well-defined process for handling critical vulnerabilities, complete with specific timelines for developing, testing, and deploying patches.
Documentation plays a critical role. Manufacturers must ensure that information about vulnerabilities is shared responsibly to reduce risks and enable remediation [9]. This includes creating standardized templates for notifying healthcare providers, offering guidance on temporary risk mitigation strategies, and setting up secure channels for distributing patches.
Automated patch management, combined with human oversight for critical devices, can streamline the process. Policies should ensure that updates addressing known vulnerabilities are distributed promptly [6]. Every patch must also undergo rigorous testing to avoid introducing new problems.
"The pace of technological change requires us to rethink our strategies for security, and embrace a proactive, not reactive, mindset" [7].
These proactive steps lay the groundwork for embedding cybersecurity into your Quality System Regulation (QSR) framework.
Maintaining Cybersecurity Plans Under QSR Framework
Once vulnerability management is in place, the next step is to integrate cybersecurity into your quality system practices. The FDA’s QSR framework treats cybersecurity as a core part of device design and development. This means manufacturers must establish and maintain procedures for validating device designs, including software validation and risk analysis - key components of cybersecurity planning [13].
A Secure Product Development Framework (SPDF) can help meet these requirements by addressing vulnerabilities throughout the device lifecycle [13]. Security should be part of the design process from the beginning, not an afterthought [14].
Manufacturers also need to document how security risk management ties into overall safety risk management [10]. These processes should be part of the Total Product Lifecycle (TPLC), ensuring that cybersecurity is considered at every stage [10].
Risk assessments are essential. Regularly evaluate vulnerabilities and cyber threats to device functionality, and update these assessments whenever significant changes occur - whether in the device itself, its environment, or the broader threat landscape [11]. Postmarket surveillance and incident reporting mechanisms are equally important for staying ahead of emerging threats [11].
Routine audits can ensure your cybersecurity measures remain effective. Conduct gap analyses to identify shortcomings and address them proactively [12].
Managing Third-Party and AI/ML Component Risks
Managing risks associated with third-party components and AI/ML technologies is another critical piece of FDA postmarket compliance. The FDA’s 2025 guidance emphasizes transparency and accountability, especially for devices that rely on artificial intelligence or machine learning. Continuous monitoring is essential for these components [3].
Keep your Software Bill of Materials (SBOM) updated to include all software components, with a focus on security objectives for AI/ML elements [3]. Past incidents, like the 2017 recall of nearly half a million wireless pacemakers due to cybersecurity vulnerabilities, highlight the importance of stringent postmarket practices. That recall not only posed risks to patient safety but also damaged the manufacturer’s reputation [5].
Threat modeling and testing should continue throughout the device lifecycle [3]. For third-party components, work closely with suppliers to gather necessary security information and maintain high standards. Using VEX (Vulnerability Exploitability eXchange) documents can help communicate whether specific vulnerabilities affect a device, enabling more targeted cybersecurity decisions [3].
Manufacturers should establish a clear Standard Operating Procedure (SOP) for postmarket vulnerability management. This SOP should cover SBOM tracking, CVE triage, and patch planning, while also defining roles, responsibilities, and timelines for addressing vulnerabilities. Escalation procedures for critical issues should be included as well [3].
Platforms like Censinet RiskOps™ can simplify third-party risk management. These tools centralize vendor security assessments, automate supplier monitoring, and provide collaborative features for handling complex vendor relationships. Their AI-powered risk assessments help scale efforts while ensuring human oversight for critical decisions.
"Cybersecurity is not just about FDA compliance - it's about protecting patient safety, ensuring medical device reliability, and safeguarding company reputations" [15].
Ultimately, success hinges on treating cybersecurity as an ongoing responsibility. This means creating flexible processes that can adapt to new threats, evolving regulations, and emerging technologies, all while meeting the FDA’s stringent documentation and validation standards.
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Summary and Key Takeaways
FDA Postmarket Cybersecurity Requirements Summary
The FDA's guidance marks a shift in how manufacturers approach device security, emphasizing it as a continuous responsibility throughout a device's entire lifecycle. This includes every phase - design, development, production, distribution, deployment, and maintenance [2].
Key aspects of the guidance focus on vulnerability management, comprehensive documentation, and continuous monitoring protocols. It also introduces measurable performance metrics to ensure accountability [16]. One of the most impactful changes is the FDA's authority to reject medical devices that lack sufficient cybersecurity measures [6]. This regulatory power firmly establishes cybersecurity as a critical element of device safety and effectiveness.
The Total Product Life Cycle (TPLC) approach integrates cybersecurity into safety risk management using the Secure Product Development Framework (SPDF) [16]. This broad perspective ensures that security is considered at every stage, encouraging manufacturers to adopt more forward-looking strategies to address evolving threats.
Final Thoughts on Compliance Success
Achieving compliance with the FDA's guidance requires a proactive approach. As highlighted earlier, robust risk management and detailed documentation are essential. The FDA underscores this by stating:
"Proactively addressing cybersecurity risks in medical devices reduces the overall risk to health" [2].
Modern medical devices, especially those using AI/ML technologies or third-party software, demand advanced risk management solutions. Manual processes alone are no longer sufficient to track vulnerabilities across large device portfolios. Tools like Censinet RiskOps™ offer an efficient way to manage risks collaboratively, conduct third-party risk assessments, and benchmark cybersecurity efforts across an organization.
A commitment to continuous improvement is vital. Cyber threats evolve rapidly, meaning yesterday's defenses may not be enough for tomorrow. Regular vulnerability assessments, ongoing staff training, and staying informed about new threats are crucial for long-term success [6].
The stakes are enormous. As Joshua Corman, vice president of cyber safety strategy at Claroty, emphasizes:
"Medical device manufacturers can no longer turn a blind eye to the risks posed to patients by security risks in the software they use" [18].
Patient safety, device reliability, and the reputation of healthcare organizations all hinge on robust cybersecurity practices. Collaboration is key - manufacturers, healthcare providers, and regulatory bodies must work together to combat cyber threats. The FDA encourages organizations to join cybersecurity information sharing analysis organizations (ISAOs) to share insights on emerging risks and vulnerabilities [17].
Ultimately, the FDA's guidance goes beyond compliance. It’s about creating a healthcare system that patients can trust, one capable of adapting to an increasingly interconnected world. Organizations that rise to this challenge will not only meet regulatory standards but also establish themselves as leaders in patient safety and cybersecurity.
A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
FAQs
What actions should manufacturers take to comply with the FDA's postmarket cybersecurity guidance for medical devices?
To meet the FDA's postmarket cybersecurity guidance, manufacturers should develop a comprehensive cybersecurity management plan. This plan should address critical areas like threat modeling, conducting risk assessments, and continuously monitoring devices once they are on the market. It’s also essential to include processes for identifying and fixing vulnerabilities, such as rolling out timely updates and patches to keep devices secure.
Manufacturers are also required to provide detailed cybersecurity documentation when submitting both premarket and postmarket applications. Staying compliant means regularly updating security protocols to counter emerging threats, ensuring devices remain protected throughout their entire lifecycle. By taking a proactive stance on cybersecurity, manufacturers can meet FDA requirements while prioritizing patient safety.
What is the FDA's definition of a 'cyber device,' and how does it determine which medical devices must meet cybersecurity requirements?
The FDA classifies a 'cyber device' as any medical device that incorporates software or depends on wired or wireless network connections to operate. These devices can share data, interact with other systems, or assist in treatment processes.
Devices falling under this category must follow the FDA's postmarket cybersecurity guidance. This means manufacturers are responsible for addressing cybersecurity risks, keeping an eye on vulnerabilities, and maintaining the device's security throughout its lifecycle. These measures are designed to protect connected medical devices from cybersecurity threats, ensuring both patient safety and the integrity of sensitive data.
What are the essential steps in a coordinated vulnerability disclosure process for medical device manufacturers?
A coordinated vulnerability disclosure process is essential for medical device manufacturers to tackle cybersecurity risks in a responsible and efficient manner. Here’s how the process typically unfolds:
- Set up a reporting channel: Develop an easy-to-use system that allows security researchers, users, and other stakeholders to report vulnerabilities. Accessibility is key here.
- Evaluate vulnerabilities: Carefully assess the reported issues to determine their severity and the potential impact on patient safety and the device’s functionality.
- Work on mitigation: Collaborate with internal teams and external partners to create and test fixes or other mitigations that address the issue effectively.
- Deploy and verify fixes: Roll out updates or patches promptly, ensuring they resolve the problem without causing new complications.
- Share information responsibly: Keep stakeholders, such as healthcare providers and regulatory agencies, informed about the vulnerability and its resolution in a clear and timely manner.
By sticking to this process, manufacturers can improve the security of their devices, safeguard patient safety, and stay aligned with the FDA's postmarket cybersecurity guidance.
