What are you missing? Understanding cybersecurity reasons for FDA approval delays

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Thought leadership
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Regulatory
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FDA readiness
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Vulnerability management
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All authors
All authors

June 5, 2024

What are you missing? Understanding cybersecurity reasons for FDA approval delays

In the ever-evolving landscape of healthcare technology, the importance of cybersecurity in software-based medical devices cannot be overstated. As medical devices become increasingly interconnected, the potential for cyber incidents grows, posing risks to patient safety and care delivery. This blog will explore key focus areas essential for bolstering cybersecurity in medical devices, including the respective regulatory requirements, the challenges faced by manufacturers, and the importance of collaboration within the healthcare ecosystem. Additionally, we will explore future trends and emerging technologies that will shape the cybersecurity landscape.

Regulatory Requirements and Compliance Standards

FDA Premarket Cybersecurity Guidance

Ensuring and demonstrating cybersecurity in medical devices hinges on good cyber engineering practices as well as adhering to regulatory frameworks, such as the guidelines set forth by the U.S. Food and Drug Administration (FDA). These guidelines are designed to ensure that medical devices are secure and do not pose undue risk to patients. Meeting these regulations is essential not only for patient safety but also to avoid delays in bringing products to market.

Regulatory delays are a significant challenge for medical device manufacturers (MDMs). According to FDA experts, common areas where MDMs fall short in their submissions to the FDA;

  • Demonstrate secure product development lifecycle (SDLC), e.g., leading to the implementation of cybersecurity-specific design controls;
  • Security-specific documentation, e.g., software bill of materials (SBOM);
  • Demonstrate successful mitigation of identified risks through traceability from requirements to testing.

The complexities of meeting these objectives and providing supporting evidence can be daunting. For example, implementing effective cybersecurity design controls require a systematic approach to product development, ensuring all design aspects are considered, and their implementation is documented. An SBOM is critical for supply chain risk management and identification of software components and their respective vulnerabilities, while comprehensive security testing ensures the device performs safely under all conditions and that the effectiveness of the design controls can be demonstrated. MDMs must meticulously document these aspects as part of their market clearance application so as to meet FDA expectations and to facilitate a smooth approval process.

Finding the right tools and services to navigate FDA approval is a necessity. For example, see Medcrypt’s SBOM buyers guide to learn what to look for in selecting SBOM and vulnerability management tools.

SBOM Tool Buyers Guide

Collaboration and Information Sharing

Effective cybersecurity in medical devices cannot be achieved in isolation. It requires robust collaboration among various stakeholders, including manufacturers, their suppliers, regulators, and healthcare providers. Information-sharing organizations like MedISAO and H-ISAC play a pivotal role in facilitating this collaboration. These organizations enable stakeholders to share knowledge, report vulnerabilities, and develop best practices collectively.

MedISAO

The recent Memorandum of Understanding (MOU) between MedISAO and the FDA highlights the growing emphasis on collaborative efforts among stakeholders to enhance cybersecurity. By sharing information and working together, the healthcare industry can better anticipate and mitigate cyber threats, ultimately leading to a more secure medical device. ecosystem

Future Trends and Emerging Technologies

As the healthcare sector continues to innovate, new challenges and opportunities emerge. The adoption of technologies such as artificial intelligence (AI) presents unique cybersecurity challenges. These technologies can enhance diagnostic quality, patient care, and operational efficiency but also introduce new vectors for cyberattacks. In the same breath in which the FDA talks about cyber devices, they discuss the same information objectives that matter for AI/ML clearance. Medcrypt’s VP Services, Naomi Schwartz, led a discussion, “Cybersecurity and AI/ML are Inextricably Linked when Dealing with the FDA,” which can be watched on demand.

Conclusion

Enhancing cybersecurity in medical devices requires a multifaceted approach. Adhering to regulatory requirements, addressing common deficiencies in FDA submissions, and fostering collaboration among industry stakeholders are crucial steps. Furthermore, staying ahead of emerging technologies and their associated cybersecurity challenges is vital.

Manufacturers must prioritize cybersecurity and invest in proactive measures to safeguard their devices. By doing so, they not only protect patients but also ensure smoother regulatory approval processes and market success. The future of healthcare depends on secure and resilient medical devices, and it is imperative for the industry to rise to this challenge.

Medcrypt provides extensive regulatory services that help MDMs navigate FDA approval:

  • FDA cybersecurity readiness
  • FDA hold letter response
  • Threat modeling
  • Cryptography design and review

Avoid approval delays from missing key cybersecurity information, get started with Medcrypt to meet FDA requirements.

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