Cybersecurity Practices for Protecting Medical Devices

Updated November 17, 2024

Medical devices have ushered in a new age of healthcare driven by innovation and technology. These additions to the ecosystem of care offer benefits for providers and their patients. However, manufacturers must adapt to regulatory requirements with cybersecurity practices for protecting medical devices.

Adhering to the rules of the Food and Drug Administration (FDA) is critical for the approval of the device and its ongoing use in the market. Going beyond the minimum requirements in developing cybersecurity strategies ensures your device is secure today and into the future.

For a quick reminder, review this checklist for protecting medical devices, with cybersecurity practices for device manufacturers.

Key Takeaways

• Submit a post-market vulnerability management plan.
• Implement consistent patching and update procedures.
• Develop and submit a complete SBOM with FDA filings.
• Maintain an agile, proactive cybersecurity strategy.
• Ensure 510(k) premarket submission requirements are met.
• build a secure-by-design culture in device development.

Table of Contents

• Key Takeaways
• Device Manufacturer’s Checklist: Must-Haves for Cybersecurity
• Get Support for Cybersecurity Best Practices for Protecting Medical Devices

Why this matters

The security of medical devices directly impacts patient safety, health system integrity, and manufacturers' market viability. Cyberattacks can lead to device malfunction, data breaches, and compromise patient data, resulting in severe clinical harm and significant reputational and financial damage. The FDA's 'Cybersecurity in Medical Devices' Final Guidance, dated February 3, 2026, emphasizes the critical need for manufacturers to integrate cybersecurity throughout the total product lifecycle, from design to post-market surveillance. Non-compliance can result in stalled device approvals, recalls, and enforcement actions, hindering market access and patient care. Adherence not only secures critical healthcare infrastructure but also aligns with relevant international standards such as IEC 81001-5-1, ISO 27001, and AAMI TIR57, demonstrating a commitment to quality and patient trust. Proactive cybersecurity protects against evolving threats, ensuring devices remain safe and effective for their intended use.

Device Manufacturer’s Checklist: Must-Haves for Cybersecurity

The list begins with all the FDA requirements, most recently restated in the Feb 3, 2026 final premarket cybersecurity guidance (which supersedes the September 2023 and June 2025 versions). They define many cybersecurity best practices to protect medical devices. In addition, manufacturers should employ protocols that ensure maximum vigilance and visibility.

Define how you will track and address cybersecurity issues that occur post-market.

Your initial premarket submission must include how you will manage cybersecurity risks after device approval and once in use. You’ll need a detailed plan of all efforts to identify and resolve any potential weaknesses. It can include penetration testing, vulnerability assessments, and other proactive cyber-attack initiatives.

Implement internal procedures for sending patches and updates to devices after locating vulnerabilities.

Your organization will need to establish a consistent method for device patches and updates. It should outline how a vulnerability triggers an update and how you’ll send it to devices.

Develop an SBOM and submit it with your FDA filings.

An SBOM is a software bill of materials. It is a formal and standardized list of every software component and its dependencies and metadata. It would include open-source and third-party software, firmware, binaries, cloud resources, and APIs (application program interfaces).

In addition, your SBOM must explain how you will monitor, identify, and address cybersecurity vulnerabilities. The FDA requires testing and protocols in the SBOM that assess risks, entry points, existing controls, and data flows.

Comply with forthcoming yet-to-be-created rules from the FDA.

While you don’t know what the FDA will issue in the future, you can prepare by having an agile, evolving cybersecurity strategy. One central philosophy for being prepared is to be proactive in your cyber best practices.

Some examples are:

• Monitoring endpoints with advanced tools
• Continuously performing pen testing and vulnerability scans and remediating after
• Reviewing your cybersecurity plans regularly for updates
• Adopting the standards the FDA recognizes as best practices: ANSI/AAMI 2700-2-1, ANSI AAMI SW96:2023, and ISO/IEC/IEEE 29119-1

Complete the 510(k) premarket submission SE requirements.

See also: When to Hire a Device Security Consultant vs. Build In-House, Cybersecurity Is Now a QMS Requirement, and Why Medical Device Cybersecurity Is Nothing Like Enterprise.

SE (substantial equivalent) was part of the 510(k) before the update and is crucial for approval. You will compare a new device to one that is similar and already approved. A device would be an SE if it has the same intended use and technological characteristics of a predicate. It can also be an SE if the same is true and it doesn’t raise any new safety and effectiveness questions, and the submission demonstrates that it is safe.

Avoid other premarket errors relating to medical device cybersecurity.

The FDA kicks back many 510(k) submissions due to mistakes. The most common include:

• Inadequate descriptions
• Discrepancies
• Usage indication problems
• Incomplete testing
• Non-compliance with standards
• Missing clinical data

Minimize the chance of these invalidating your premarket approval by partnering with a firm that specializes in medical device cybersecurity.

Create and sustain a secure-by-design culture.

Security considerations should be part of any new device product development. Don’t ignore it until the end. You’ll lose time and money. At the launch of your cycle, confer with medical device cybersecurity experts to understand the implications and protect the equipment from the onset.

Get Support for Cybersecurity Best Practices for Protecting Medical Devices

The regulatory and cyber environment for medical devices keeps evolving. It’s hard for manufacturers to keep up. You can get the support you need to meet standards and protect devices with us. We’re experts ready to help. Get in touch to learn more.

How Blue Goat approaches this

Blue Goat Cyber assists medical device manufacturers in developing and implementing cybersecurity practices that meet and exceed regulatory expectations. Our approach integrates security into every stage of the product lifecycle, from initial concept through post-market support. We specialize in preparing FDA premarket submissions, including vulnerability management plans, threat modeling, and SBOM generation. Our team, comprised of professionals with CISSP, OSCP, and ex-military red team backgrounds, offers deep expertise in identifying and mitigating potential security weaknesses. We perform targeted penetration testing and security assessments to validate device integrity. Our objective is to streamline the compliance process, minimize risks, and get your devices to market efficiently. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost. Explore our FDA Premarket Cybersecurity Services to learn more about our methodology.

FAQ

What is the FDA's primary cybersecurity guidance for medical devices?

The FDA's primary cybersecurity guidance is the February 3, 2026 final guidance, which outlines the agency's expectations for premarket submissions regarding device cybersecurity. It details requirements for risk management, vulnerability disclosure, and secure product development.

Why is an SBOM important for medical device cybersecurity?

An SBOM is critical because it provides a complete inventory of all software components within a medical device, including third-party and open-source elements. This transparency enables effective vulnerability tracking and management, which is an FDA requirement.

What does 'secure-by-design' mean in medical device development?

Secure-by-design means integrating cybersecurity considerations from the very initial stages of device conceptualization and development, rather than incorporating them as an afterthought. This approach minimizes vulnerabilities and reduces costs associated with retrofitting security.

How can manufacturers prepare for future FDA cybersecurity regulations?

Manufacturers can prepare by adopting an agile, evolving cybersecurity strategy that includes proactive measures like continuous monitoring, regular penetration testing, and adhering to recognized standards such as ANSI/AAMI 2700-2-1 and ANSI AAMI SW96:2023.

Related: The Rising Tide of Cyber Threats in Medical Devices: Understanding the Risks

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About the author

Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance. Read more about Christian.