Sherman Eagles of SoftwareCPR® provides the following summary of some key points from FDA’s webinar on their premarket cybersecurity guidance on October 29.
In the webinar FDA noted that the Instructions for Use should include what cybersecurity controls are needed in the use environment, but stated that it is not sufficient for a device to rely on a network being secure. The device manufacturer should identify the cybersecurity functions they have included in their device. Some of the core functions include:
- Limiting access to trusted users by using layered privileges, appropriate authenticity, and strong passwords.
- Protecting users and data by terminating sessions after a period of inactivity, setting up physical locks, and limiting access ports.
- Detecting, responding and recovering by implementing features that tell a user if the device has been compromised, provide information on what to do when it occurs, implement features to preserve critical functions with the ability to reboot and recognize drivers, and provide methods for retention and recovery of device configuration.
They also expect to see a hazard analysis program that clearly evaluates risk potential, provides information on controls put in place and the appropriateness of those controls to mitigate an identified risk, and a matrix that links cybersecurity controls to the risk being mitigated. Since the threat landscape will be continually evolving, they also want to see a plan for how the manufacturer will manage evolving threats. In response to a question, they indicated that updates for cybersecurity needed to manage new threats do not require a new premarket submission. Other questions brought out these points:
- Cybersecurity information is required for all submissions after October 1, 2014
- Risk to the system as a whole must be acceptable
- Mobile apps intended to control a device would need to consider cybersecurity
- Cybersecurity should be considered for any programmable logic – that is hardware functionality that can be re-programmed
- There is no requirement for minimum strength of encryption, but they expect a rationale from the manufacturer for the encryption chosen
- A software device delivered from the cloud should consider environment and analyze it for cybersecurity risks
- Labeling could be used to mitigate cybersecurity risks if it clearly informs the user of the needed mitigations