Over the past decade, the FDA has steadily increased the degree of scrutiny applied to cybersecurity aspects of submissions. From the guidance issued on this topic in 2014, followed by extensive additions on the 2018 guidance and most recently the 2022 guidance, the FDA has made it clear that cybersecurity management needs to be carefully considered within 510(k) applications. In the latest update that has become effective as of March 29, 2023, the FDA now reserves the right to refuse your 510(k) application due to cybersecurity deficiencies under certain circumstances. This shift reflects a growing recognition of the importance of cybersecurity in maintaining the safety and effectiveness of medical devices that rely on software and connectivity.
Cybersecurity Refusal Reasons:
#1: The application does not include an adequate plan to address post-market cybersecurity vulnerabilities in a reasonable time. A plan like this would include how such vulnerabilities are identified, monitored, and disclosed. For example, manufacturers should establish frameworks for continuous monitoring of their devices for emerging threats and vulnerabilities, utilizing tools such as threat intelligence platforms and conducting regular audits of security measures.
#2: The application does not contain evidence that the medical device design and development has followed processes and procedures that provide reasonable assurance that the device is cyber secure. This encompasses the implementation of secure coding practices, conducting thorough risk assessments, and applying robust validation and verification processes throughout the development lifecycle.
#3: The medical device within the application does not have the means to be updated post-market to address discovered cybersecurity threats. These updates would be required either on a reasonably justified regular cycle or possibly out of cycle to address a critical vulnerability. Manufacturers must demonstrate their capability for over-the-air updates or provide an easily accessible means for users to install patches to mitigate risks rapidly.
#4: The application does not contain an appropriate software bill of materials that includes any open source software as well as commercial software used within the medical device. A comprehensive software bill of materials (SBOM) not only aids in transparency but also helps in identifying vulnerable components, ensuring that manufacturers can act swiftly upon discovering security flaws in third-party software.
#5: The application does not comply with any additional requirements that the FDA may impose through regulation to demonstrate with reasonable assurance that the medical device is cybersecure. This can include specific guidelines related to the authentication of devices, encryption standards, and incident response plans, all of which are critical in fostering trust and safety in medical technology.
Ultimately, if your medical device has software and has connectivity to the Internet, it has now become a prime target for outright refusal of a 510(k) submission for lack of adherence to the rapidly evolving FDA regulations in this area. Driven mainly by new laws as a result of the Consolidated Appropriations Act of 2023, specifically section 3305 titled “Ensuring Cybersecurity of Medical Devices” and subsequent amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) section 524B, these new cybersecurity regulations need to be seriously considered in any 510(k) submission to avoid costly delays. The evolution of the regulatory landscape necessitates that manufacturers go beyond mere compliance; they must adopt a proactive approach towards cybersecurity as an integral part of their device lifecycle management.
At CyberMed we have always taken cyber security concerns seriously and incorporated extensive measures to address these concerns as part of our ISO 13485 compliant processes and procedures. Our commitment to cybersecurity extends through all phases of device development, from initial concept through post-market surveillance. We have been prepared for the inevitable and well-deserved increase in 510(k) scrutiny over cybersecurity threats, fundamentally addressing such concerns in our software architectures as well as within our 510(k) submissions. This foresight has enabled us to maintain the integrity and security of our devices while ensuring compliance with FDA requirements.
For us, cybersecurity of connected Medical devices is foundational which is why we make sure we are well positioned to comply with the evolving FDA regulations in this space. Our team stays updated on the latest advancements in cybersecurity technology and regulatory expectations, allowing us to integrate best practices into our processes and provide the most robust solutions to our clients.
When it comes to safeguarding your connected Medical Devices to ensure a smooth FDA submission and avoid costly mistakes, CyberMed is the team to rely on. Our expertise in navigating the complex regulatory landscape and our commitment to maintaining security and compliance can help streamline the approval process for your medical devices. Contact us today to learn how we can assist you in achieving your cybersecurity goals and ensure a successful 510(k) submission.
Reference: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act, March 30, 2023 https://www.fda.gov/media/166614/download