The FDA has developed guidelines for the cybersecurity of medical devices. These guidelines help manufacturers identify and manage security risks throughout the life of a device. They stress the need for good risk management practices, which include spotting potential threats, putting protective measures in place, and preparing for possible incidents. The FDA expects manufacturers to include cybersecurity considerations in their design and development processes to ensure patient safety and protect data.
One important document from the FDA is the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” This document lays out what manufacturers need to do, such as:
- Providing details about the device’s cybersecurity features
- Conducting assessments to find vulnerabilities
- Outlining strategies for monitoring the device after it is on the market
Following these guidelines is crucial for getting regulatory approval and building trust with healthcare providers and patients.
Section V.A.4 discusses how Software Bills of Materials (SBoMs) can help manage cybersecurity risks in software. SBoMs are detailed lists that include all software components in a device—both those created by the manufacturer and those from third parties, like purchased or open-source software, as well as their dependencies.
SBoMs are important not just during the development phase for selecting software but also throughout the product’s life. They help identify devices that could be affected by software vulnerabilities.
SBoMs also play a key role in managing vulnerabilities, which is vital for the overall security of a device. They should be regularly updated to reflect any software changes in devices that are already on the market.
In Section VI, titled “Cybersecurity Transparency,” the FDA emphasizes the importance of transparency for safely using and integrating devices and systems. The FDA recommends labeling devices with cybersecurity risk information to enhance security and visibility in the software supply chain.
According to the FDA, medical device labels must meet certain standards, specifically sections 502(f) and 502(a)(1) of the FD&C Act. This ensures that usage instructions are clear and not misleading. Manufacturers should include security information on their labels as part of their design and development processes to address cybersecurity risks and ensure device safety and effectiveness. They should also consider usability testing in their risk management strategies.
The FDA lists examples of what security information could be included on labels, advising that manufacturers should use an SBOM, as mentioned in Section V.A.4, or a widely accepted format, to:
- Manage their assets
- Assess how vulnerabilities affect medical devices
- Maintain device safety and effectiveness
Manufacturers should continuously provide accurate SBoM information, making it easy to access, ideally in a machine-readable format. This is summarized in Section VI.A.
The FDA’s Final Guidance requires that SBoMs be submitted as part of a medical device’s General Premarket Submission Documentation, as noted in Appendix 4.
SBoMs not only help maintain ongoing visibility into the vulnerabilities and threats in the software supply chain of connected medical devices but also assist in meeting the stricter regulatory requirements for submission and approval.