Precision and accuracy play critical roles in medical device development as it is these factors that determine the validity of what a device claims to do. The FDA has guidelines that refer to calibration measures for instruments and such. In addition, in the case of instrumentation, the device in question has to produce consistent outputs with respect to the “golden standard” the FDA sets out. Things like a device’s measurement resolution can also play into this depending on the application, but no matter what, it still has to meet FDA standards; otherwise the company risks shutdown and even legal repercussions. The reason things like accuracy and precision is so important to the FDA is because a lack of accuracy and precision in devices can result in a misdiagnosis and other preventable complications.