Improve Cybersecurity in Medical Devices and Navigate FDA Guidance with Mayhem

Debra Hopper
January 18, 2024
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The FDA guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, released September 25, 2023, provides recommendations on medical device cybersecurity and what information to include in premarket submissions.

The recommendations cover cybersecurity device design, labeling, and the documentation that the FDA advises be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

This blog post delves into the key recommendations, the scope of the guidance, and practical steps medical device manufacturers can take to seamlessly comply with the FDA's directives while ensuring the safety and reliability of connected medical devices.

Why is the FDA guidance for medical devices needed?

As medical devices increasingly connect wirelessly and exchange information electronically, they are more susceptible to attack. The FDA's guidance draws attention to various instances of cybersecurity threats posed to medical devices, including WannaCry, URGENT/11 and SweynTooth, and the 2020 Düsseldorf University Hospital attack.  

These incidents collectively demonstrate the diverse areas within medicine and healthcare that are susceptible to cyber threats, ultimately posing risks to patient safety.


In 2017, the WannaCry ransomware attack had global repercussions, impacting hospitals and medical tools and causing significant delays in patient care. This event underscored the vulnerability of healthcare infrastructure to malicious cyber activities.

URGENT/11 and SweynTooth

Widely employed third-party components in medical devices, such as URGENT/11 and SweynTooth, present vulnerabilities that hackers can exploit. This susceptibility raises concerns about the potential compromise of devices like pacemakers and blood glucose monitors, emphasizing the critical need for robust cybersecurity measures.

Düsseldorf University Hospital Attack

A notable incident in 2020 involved a cyberattack on a German hospital that diverted critically ill patients to an alternative facility. The repercussions included delays in patient care and, arguably, a woman's death.

Preventing Future Attacks on Medical Devices and Systems

The FDA's guidance underscores the necessity for enhanced cybersecurity measures to counter evolving threats. Emphasizing a proactive approach, it highlights the crucial importance of designing these devices with security in mind and implementing effective mitigation strategies to mitigate potential risks.

FDA Guidance Overview

The FDA guidance outlines critical considerations and recommendations for ensuring the cybersecurity of medical devices throughout their lifecycle. The document emphasizes the growing importance of cybersecurity in the context of increased integration of wireless and network-connected capabilities in medical devices. With the rise of cybersecurity threats to the healthcare sector, the guidance underscores the need for robust controls to ensure the safety and effectiveness of medical devices.

What does the FDA Medical Device Guidance cover? 

The scope of the guidance is large, covering various types of devices, including those with device software functions or containing software and firmware. The guidance recognizes that increased connectivity has led to devices operating as parts of larger medical device systems, emphasizing the importance of cybersecurity considerations across all components to prevent threats that may compromise device safety and effectiveness.

Embracing Connectivity While Managing Risks

The guidance starts by acknowledging the increasing integration of wireless, internet and network-connected capabilities in medical devices. With portable media, electronic data exchange, and the prevalence of software in healthcare devices, the potential impact of cybersecurity threats on patient care has risen significantly. The FDA emphasizes the importance of robust controls to address these risks and prevent disruptions in healthcare delivery.

Comprehensive Scope and Applicability

The scope of the guidance is vast, covering a wide range of medical devices, including those with software functions or containing software and firmware. It extends its recommendations to various premarket submission types, such as 510(k) submissions, De Novo requests, Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Investigational Device Exemption (IDE) submissions, Humanitarian Device Exemption (HDE) submissions, Biologics License Application (BLA) submissions, and Investigational New Drug (IND) submissions.

Collaborative Responsibility for Cybersecurity

Recognizing that medical device cybersecurity is a shared responsibility, the guidance highlights the interconnected web of stakeholders, including healthcare facilities, patients, healthcare providers, and manufacturers.

Evolution from Previous Guidance

The FDA's new guidance replaces the 2014 cybersecurity guidance and aligns with or expands upon recommendations in other relevant documents. It reflects the agency's commitment to staying abreast of the rapidly evolving landscape, understanding emerging threats, and deploying effective mitigations throughout a medical device's total product lifecycle (TPLC).

Adapting to Legislative Changes

The document also addresses recent legislative changes, specifically section 524B of the FD&C Act, enacted in 2022. This section mandates specific cybersecurity requirements for devices meeting the definition of a "cyber device." The guidance provides insights to help manufacturers meet their obligations under this new legislative provision.

Takeaways for Medical Device Manufacturers and Development Teams

The FDA guidance applies to a wide range of stakeholders involved in the development and regulatory processes of medical devices. Specifically addressing device manufacturers, the guidance outlines a series of recommended measures aimed at fortifying the cybersecurity resilience of medical devices.

Secure Product Development Framework (SPDF)

Firstly, the guidance advocates for the integration of cybersecurity measures at the early stages of the development process. This involves the adoption of a Secure Product Development Framework (SPDF), strategically implemented to diminish vulnerabilities across the entirety of the device lifecycle. This proactive approach emphasizes the importance of building security into the very foundation of the device.

Documentation and Risk Assessments

Additionally, manufacturers are urged to provide comprehensive documentation and conduct meticulous risk assessments, particularly for software components, with special attention given to third-party elements. This thorough examination helps identify potential vulnerabilities and allows for the implementation of targeted security measures.

Robust Testing

The guidance emphasizes the significance of robust cybersecurity testing, encompassing penetration testing and vulnerability testing at various stages of development. Importantly, manufacturers are advised to maintain detailed records of testing results, which are then to be included in premarket submissions. This not only facilitates transparency but also serves as a critical step in verifying the safety and effectiveness of medical devices.

Address Known Vulnerabilities

To further bolster cybersecurity, the guidance recommends the prompt addressing of known vulnerabilities through safety and security risk assessments. This proactive identification and mitigation of risks contribute to an overall more secure device environment.


Finally, the adoption of Software Bill of Materials (SBOM) practices is encouraged to aid in the identification of devices affected by known vulnerabilities. This practice enhances traceability and provides a comprehensive inventory of software components, contributing to effective vulnerability management.

How Can Device Manufacturers Comply With The FDA Guidance Easily?

Though navigating the FDA guidance for cybersecurity in medical devices poses a challenge for medical device manufacturers, complying with the guidance is essential for both regulatory compliance and patient well-being. By diligently adhering to these recommended measures, manufacturers can significantly elevate the cybersecurity posture of their medical devices. The FDA's guidance will only become more crucial for patient safety and healthcare system integrity as healthcare advances and devices become more interconnected. 

FDA Guidance with Mayhem

Mayhem is a versatile solution that not only identifies vulnerabilities but also facilitates compliance with FDA guidance by generating dynamic SBOMs, matching vulnerabilities with CWE categories, and providing comprehensive reports on various cybersecurity tests. 

To learn more about using Mayhem to not only meet FDA requirements but to proactively safeguard your connected medical devices, contact us or download our guide.

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