In September 2023, the FDA's issued guidance on "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" which outlined critical recommendations for medical device manufacturers to ensure the security and safety of their products. This comprehensive guidance applies to a wide range of devices, including those with software functions, programmable logic, or connectivity capabilities. After nearly two years of helping Medical Device manufacturers work through this guidance, we thought it would be helpful to share some of the key points that comprise this guidance.
One of the key principles emphasized in the guidance is that cybersecurity is an integral part of device safety and effectiveness and must be addressed throughout the total product lifecycle (TPLC). Manufacturers are expected to establish and maintain quality systems that account for cybersecurity risks, using processes such as a Secure Product Development Framework (SPDF).
The guidance provides detailed recommendations on various aspects of cybersecurity risk management:
- Security Risk Management: Manufacturers should conduct thorough threat modeling, cybersecurity risk assessments, and vulnerability analyses to identify and mitigate risks throughout the TPLC. This can involve services such as penetration testing, vulnerability scanning, and secure architecture reviews.
- SBOM: The guidance recommends that manufacturers generate a security risk management plan, which should include documentation on threat modeling, cybersecurity risk assessment, a Software Bill of Materials (SBOM), component support information, vulnerability assessments, and an assessment of unresolved anomalies.
- Security Architecture: The FDA recommends providing detailed documentation on the security architecture of the medical device system, including global, multi-patient, and updateability views. This can be supported by security design and architecture reviews. The security architecture reviewshould define the system and all end-to-end connections, and demonstrate how the controls to address cybersecurity risks have been applied. Manufacturers should provide diagrams and explanatory text detailing the communication paths, protocols, authentication mechanisms, and other security-relevant information.
- Cybersecurity Testing: Comprehensive security testing, including vulnerability testing, abuse case analysis, and penetration testing, is crucial to validate the effectiveness of security controls. The guidance recommends that manufacturers provide documentation on security requirements testing, threat mitigation testing, vulnerability testing, and penetration testing in their premarket submissions.
- Cybersecurity Transparency: The guidance emphasizes the importance of providing clear and comprehensive cybersecurity information in device labeling, as well as establishing a cybersecurity management plan to address vulnerabilities over the device's lifecycle. Consulting services can assist with developing these plans and labeling recommendations.
- Cybersecurity Management: Manufacturers' cybersecurity management plans should include elements such as personnel responsibilities, vulnerability monitoring and identification sources, vulnerability remediation timelines, update processes, and a coordinated vulnerability disclosure process.
By addressing these key areas, medical device manufacturers can demonstrate a reasonable assurance of safety and effectiveness, as required by the FDA. Security services from Security Innovation that can support these efforts include threat modeling, risk assessments, secure architecture review, and penetration testing. Security Innovation's expertise in medical device cybersecurity can assist manufacturers in meeting the FDA's recommendations and ensuring the security and safety of their products throughout the total product lifecycle.