The FDA’s main priority is to make sure all regulated products are safe and effective. A device that is both precise and accurate is necessary for both of these requirements.

Often, when a device is first conceptualized, it worth pursuing if it is at least one or the other. Maybe the device only works correctly half of the time so the precision needs to be worked on. Conversely, if the device is consistent but ultimately fails to complete the therapeutic treatment it must be fixed to be more accurate.

Both of these aspects will have to be rigorously tested to ensure the safety and efficacy of the device.