The accuracy of the device qualifies how it performs in comparison to existing values. With precision, the FDA evaluates if the device is functioning as required and with the same accuracy every time it is tested repeatedly. Accuracy and precision are of the utmost importance for medical devices to be validated. If a medical device isn’t precise or accurate the FDA will not approve the device for general usage.
Precision and accuracy are the most important aspects that need to be examined very carefully to make sure the data is as close as possible with very little tolerance. Especially for biomedical implants/devices, it's definitely something that cannot be let go of, as our lives are totally dependent on it in most cases. In general, both accuracy and precision play different roles. Accuracy makes sure that a device provides outputs that are close to accepted standards. For instance, a blood pressure measurer should provide accurate units so that a patient can be guided correctly for his/her treatments. Precision, on the other hand, is all about being consistent with that accuracy—using the same example, and providing consistently accurate results while measuring the BP of that person.
The FDA is strict with regulations for validating a device before it is approved for the market because any failure in precision or accuracy could pose significant risks to a patient's life. It could also cause the public to lose trust in the organizations or government bodies responsible for protecting citizens.
To add onto this, precision and accuracy starts from the 'ground-up' on a medical device. By this I mean that each and every single component that make up the medical device is evaluated separately to ensure the overall assembled device meets the desired output. I have not worked specifically in a company that designs medical devices, but I imagine it goes something like this: medical device company designs device and communicates with FDA throughout->an output is agreed upon between the customer and the FDA->the company translates these requirements into device requirement and other relevant forms->they work in-house on the device or send them out to be produced in a prototyping or manufacturing house-> each component is produced and tested to spec. The spec (specification) is set by the customer-likely to meet their expectation of the device output and their alignment with the FDA as well. For example, a gripper to be used during Laparoscopic surgery must meet a minimum grip force of 80kN. The device is also tested to understand life cycle after cyclic use. In this way the product output accuracy and precision is also controlled (with calibration as mentioned).
