Once your medical device has passed the FDA Pre-Market Submission process, you might feel a sense of accomplishment—but the work isn’t done. Ensuring your device's cybersecurity remains strong while it’s in use is crucial. The FDA’s Post-Market Cybersecurity Requirements focus on monitoring, detecting, and responding to cybersecurity vulnerabilities throughout the device’s life cycle. This guide will walk you through the key post-market cybersecurity steps and provide actions to help you stay compliant, protect patients, and ensure device security.
Medical devices are more connected than ever. From pacemakers to insulin pumps, these devices often communicate with other devices or systems over networks. This connectivity opens up new risks—whether it’s from hackers exploiting vulnerabilities or simply new software bugs that emerge after deployment.
Post-market cybersecurity ensures that manufacturers continue to monitor and secure devices in real-world use cases. Patient safety is at the forefront. A vulnerability in a connected medical device could directly impact its performance, potentially leading to life-threatening situations. Additionally, breaches of healthcare data can have regulatory, financial, and repetitional consequences.
That’s why the FDA requires manufacturers to actively manage cybersecurity risks post-market, not just during development.
Here’s what the FDA expects from medical device manufacturers regarding post-market cybersecurity, broken down with practical actions to guide you:
The FDA expects manufacturers to maintain a risk-based approach throughout the lifecycle of their product. After a device is released, new vulnerabilities or attack vectors might surface. The FDA requires manufacturers to continuously evaluate cybersecurity risks to their devices, particularly those that could affect patient safety or device functionality.
The process doesn’t end once the device hits the market. You need to remain vigilant about new and evolving threats, continuously assessing how they could impact your device and putting mitigations in place when necessary.
Actions:
Vulnerabilities in medical devices are bound to emerge post-market. The FDA requires manufacturers to monitor for these vulnerabilities, both through internal systems and external sources like the National Vulnerability Database (NVD).
Monitoring involves continuously scanning the device for potential threats, whether they stem from the device’s software or external systems it interacts with. The FDA expects swift action when a vulnerability is identified, with manufacturers reporting serious issues that affect safety or efficacy.
Actions:
Cybersecurity isn’t a one-time task; it’s ongoing. Medical devices, like any other software-driven products, need regular updates to stay secure. The FDA requires manufacturers to provide timely software updates and patches to fix vulnerabilities as they arise.
However, it’s not just about patching—it’s about doing it in a way that doesn’t disrupt device functionality. The FDA emphasises testing patches thoroughly before deployment to ensure they don’t create new issues.
Actions:
Even with robust cybersecurity in place, incidents may still occur. The FDA requires manufacturers to have an incident response plan for cybersecurity breaches. This includes being prepared to handle real-time attacks or vulnerabilities and responding in a way that minimises impact on both the device and patient safety.
Your incident response plan should detail how you will identify, address, and recover from incidents. It also needs to outline how you’ll notify users, healthcare providers, and the FDA when a significant breach or vulnerability arises.
Actions:
The FDA encourages manufacturers to establish a Coordinated Vulnerability Disclosure (CVD) program. This program allows security researchers, customers, and other stakeholders to report vulnerabilities directly to you. This process ensures that any potential flaws in the device can be identified and resolved before they become a threat.
A CVD program builds trust with the security community and provides a structured way for stakeholders to report vulnerabilities. The FDA views this as a proactive measure to prevent unreported vulnerabilities from being exploited in the wild.
Actions:
Proactively managing cybersecurity risks after your device is on the market offers several important benefits:
Cybersecurity doesn’t end once your device is approved by the FDA. The real work begins when your product is in the field, interacting with real-world networks and data systems. By following the FDA’s post-market cybersecurity requirements, you can stay ahead of emerging threats, ensure patient safety, and maintain compliance.
Post-market cybersecurity is about being proactive. By continuously monitoring, patching, and managing vulnerabilities, you can provide a safer, more secure product that meets regulatory expectations and exceeds customer trust.
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Whether you're setting up your vulnerability monitoring system or refining your incident response plan, At Periculo we can guide you every step of the way. Click here to schedule a free strategy call with me Harrison and get personalised advice on strengthening your post-market cybersecurity today!