As of September 2023, all medical device manufacturers (MDMs) must demonstrate their device’s adherence to FDA cybersecurity standards in their premarket submission. Following medical device cybersecurity standards can be the difference between approval or not.
The FDA has released guidance documents that outline how medical device manufacturers should handle cybersecurity. These guidelines are not legally binding but are strongly recommended. Still, they will impact your approval process, so they’re important to understand.
While it’s best to consult official documentation or to reach out to an expert for help, this article is here to help guide you through the FDA’s cybersecurity requirements. We’ll explore the key standards, why they matter, and how you can ensure they’re implemented.
Key FDA Cybersecurity Standards
Manufacturers must conduct risk assessments to identify vulnerabilities and threats to their medical devices. They also must provide the FDA with documentation that showcases the cybersecurity precautions taken. What you must do varies based on your device’s risk tier.
Software Bill of Materials (SBOM)
A software bill of materials (SBOM) is a detailed list of all the software components used in a medical device. It includes the names of the software, their versions, their sources, and mandates regular scans for vulnerabilities within these components. Each identified vulnerability must undergo a thorough assessment as part of the overarching risk management strategy.
If a security issue arises in one of the software components, the SBOM makes it easier to pinpoint the problem and take immediate action. For this reason, the FDA requires that manufacturers submit an SBOM as part of their premarket review. Post-market monitoring is also required to meet FDA requirements.
Even after a device is on the market, manufacturers must monitor it for cybersecurity issues and release patches or updates as needed. This continual process is assurance that the device will remain secure as cybersecurity threats evolve.
For FDA approval, manufacturers must submit a plan outlining how they will monitor and address cybersecurity vulnerabilities after the device is on the market. This plan should detail the procedures for regular security assessments, issuing patches, and communicating updates to healthcare providers.
Manufacturers must disclose how they have and will manage cybersecurity risks. They should also work with healthcare providers to ensure continued device security. This collaboration is key for effective security risk management and quick responses to any detected issues.
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The Importance of Documentation in Design & Development
Even if you design your device perfectly for the FDA’s medical device cybersecurity standards, it won’t matter much in your approval process if you don’t have the proper documentation. Designing for cybersecurity without properly recording actions taken is a common mistake. However, it can be a costly one if you’re looking for timely market approval.
What to Record in Your Cybersecurity Documents For The FDA
1. Your Cybersecurity Risk Assessment
In your FDA submission, make sure to include a detailed cybersecurity risk assessment for your medical device. This assessment should consider the larger system where the device will operate. Specify whether the device is a standalone unit or part of a network, as this affects its potential risks.
2. Design Controls
Your submission should outline the design controls you’ve implemented based on the risk assessment. Clearly state the security controls for both hardware and software components. If the device has higher cybersecurity risks, elaborate on the more substantial design controls you’ve put in place.
3. Evidence of Safety and Effectiveness
Include specific evidence that proves that your device’s cybersecurity measures are effective. This could be test results, third-party certifications, or other forms of validation. This evidence should align with the FDA’s guidelines on what constitutes reasonable assurance of safety and effectiveness.
4. Use Environment
In your documentation, mention the intended and actual use environment of the device. Explain how your cybersecurity measures are designed to function effectively in these settings.
5. Legal Compliance
Ensure that your documentation complies with legal requirements, such as sections 502(f) and 502(j) of the FD&C Act. State that your device labeling includes adequate directions for use to avoid being considered misbranded.
6. Updates for Evolving Risks
Your submission must indicate a plan for updating the device’s cybersecurity controls. Mention how you intend to keep the device secure against new and evolving cybersecurity threats.
7. Consistency Across Submissions
State in your documentation that the same cybersecurity measures and information are included in all types of premarket submissions to the FDA. This ensures that the FDA can consistently assess the safety and effectiveness of your device across your various submissions.
Need Help Implementing & Recording Your Medical Device Cybersecurity Standards?
As you can see, there are a lot of moving parts involved in ensuring FDA cybersecurity compliance and ensuring your measures are adequately documented. As such, we recommend designating those responsible for overseeing these processes at the beginning of your device development process.
If you need help with this, you can count on medical device design and development experts from RBC Medical Innovations. Our team diligently keeps up-to-date with evolving FDA standards and has decades of experience bringing devices to market.
Let us know what your idea is and we can work together to make it a reality.