M
Hi,
I am trying to understand how to Classify a medical system that has 2 subsystems, where each subsystem poses a different risk.
For example, a system that has an active cardio-vascular implant and an external RF component.
How would one go about classifying this? and more importantly - can anyone provide a link to the FDA site that deals with this issue?
Thanks!
I am trying to understand how to Classify a medical system that has 2 subsystems, where each subsystem poses a different risk.
For example, a system that has an active cardio-vascular implant and an external RF component.
How would one go about classifying this? and more importantly - can anyone provide a link to the FDA site that deals with this issue?
Thanks!
