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Here’s what the FDA looks for when reviewing medical device cybersecurity during the pre-market submission process:
The FDA requires that manufacturers take a risk-based approach to cybersecurity. This means that during the design and development phases, you should be identifying potential risks to the device, particularly those that could affect its performance or safety.
The FDA expects that manufacturers will not only identify risks but also show how they have mitigated those risks to acceptable levels. The key here is to be thorough and proactive—waiting until the end of development to address risks can lead to costly delays.
Action: Start with a comprehensive risk management plan that includes a full assessment of potential vulnerabilities. Make this a living document that evolves as your device goes through development and testing. This will not only help during the pre-market submission but will also position your company well for post-market surveillance (which the FDA also requires).
Next on the list is threat modelling. The FDA expects manufacturers to perform threat modelling to identify potential cybersecurity risks that could impact the device. You should analyze how your device interacts with its environment, how it handles sensitive data, and what attack surfaces may exist.
For instance, if your device transmits patient data over a network, you should consider how that data might be intercepted, altered, or accessed by unauthorised users. Similarly, devices that connect to external systems (like hospital networks) may present new vulnerabilities that must be assessed.
Action: Use structured threat modelling methodologies like STRIDE (Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege) to systematically evaluate your device’s vulnerabilities. By mapping out the possible threat scenarios, you’ll be able to prioritise which areas require the most attention and mitigation.
One of the newer requirements from the FDA is providing a Software Bill of Materials (SBOM) for your device. An SBOM is essentially a list of all the software components, both proprietary and open-source, that are used in your product. The FDA requires this because it helps them (and you) quickly identify vulnerabilities that may arise from third-party software components.
With the rising complexity of medical devices, many include third-party software libraries or modules that may have known vulnerabilities. Having an SBOM allows the FDA to understand what your device is built on and enables faster responses if a vulnerability is discovered in one of those components.
Action: Keep an up-to-date SBOM throughout your product’s lifecycle. Ensure you have processes in place to identify vulnerabilities in any third-party software, and patch them as soon as updates become available.
In your submission, you’ll need to outline the security controls that have been implemented to mitigate cybersecurity risks. These controls should address both technical and operational risks, and they should be built into the design of the device—not added on as an afterthought.
Security controls include measures like:
These controls should align with industry best practices and address the specific risks identified in your threat model.
Action: Focus on implementing Security by Design—build security into the product from the ground up. This includes setting up proper access controls, encrypting sensitive data, and ensuring that all actions on the device are logged for future auditing. By integrating these controls early, you’ll avoid having to retrofit them later on.
To satisfy the FDA’s requirements, you’ll need to demonstrate that the security controls you’ve implemented are effective. This means conducting rigorous cybersecurity testing on your device, including:
The results of these tests should be included in your submission to show the FDA that your device has been tested against real-world threats and that the identified risks have been appropriately mitigated.
Action: Conduct ongoing penetration testing throughout the development process, not just at the end. This allows you to catch security flaws early, when they’re easier (and cheaper) to fix.
Finally, the FDA expects manufacturers to have a cybersecurity incident response plan in place for when things go wrong. Even with the best security controls, there’s always a chance that a vulnerability could be exploited. Your incident response plan should outline how you will:
This plan should cover both pre-market and post-market activities, as the FDA expects ongoing monitoring and response to cybersecurity threats even after your device has been approved and is on the market.
Action: Develop a comprehensive post-market monitoring plan that includes regular updates and patches. It’s also helpful to have a communication plan in place for notifying users and regulators in case a vulnerability is discovered.
Meeting these cybersecurity requirements during the FDA pre-market submission process does more than just ensure compliance—it sets you up for long-term success.
Cybersecurity is a core component of the FDA pre-market submission process for medical devices, and it’s something that all manufacturers need to take seriously. By following a risk-based approach, implementing strong security controls, and ensuring continuous monitoring and response, you’ll be well on your way to getting your device approved and onto the market.
Remember, cybersecurity isn’t just about compliance—it’s about building a safer, more trustworthy product that healthcare providers and patients can rely on.
By adopting these free resources and basic steps, you’re not only setting a solid foundation but also positioning your company to succeed in high-stakes RFPs and RFIs. These standards—whether it’s Cyber Essentials, ISO 27001, or NHS-specific requirements—are all about building trust and credibility, both of which are invaluable as you scale your business in the digital health space.
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