Precision and accuracy are both fundamental aspects of medical devices to not only the FDA but those developing the device as well. In order for a product to be functional and successful, one aspect cannot be without the other. If a device is precise but not accurate, then it is not performing at the level that it should be. In other words, it is not fulfilling the need it was meant to fulfill, instead it is doing some other purpose. If a device is accurate but not precise, then it is an inconsistent device, which is arguably a bigger problem. If you cannot predict how the device will act reliably, then it is really a liability, since you won’t know if the device will work when you want it to. However, if you have both precision and accuracy, then the device performs at the level you want it to be fulfilling the need it is meant to fill, reliably. These characteristics are ones that are standard, meaning that one would expect a medical device to have them from the very start. In other words, having precision and accuracy is not a bonus but a prerequisite most times. This is true not only for medical devices, but for products in general.