Accuracy refers to how a measurement is close to the right or acquired absolute value while precision how a measurement matches the same exact value being estimated. Both fields are independent. Which means a measurement may be highly precise but inaccurate, and vice versa.
Both accuracy and precision are essential to be insured in medical device development, which is the responsibility of FDA as well as the manufacturer. Device efficiency cannot be altered as any small error or uncertainty in calibrating a medical instrument or performing a lab test would lead to a deficiency in patient safety standards and to public risk.
All medical devices industry are controlled by FDA’s 21 CFR Parts 11 & 820, Quality System Regulation (QSR) & ISO 13485 (Ref. medicaldesignbriefs website). Both accuracy and precession are important for FDA because maintaining human health and safety is their highest priority and main preference. This involves medical instrument calibration regulations which require any medical device industry to ensure device inspection and test it until it meets the acceptable standards to check the accuracy and precession of the device and efficiency level as many devices degrade by time. This includes stents inspecting, needles, catheters, Thermometers, etc. Failing in performing the appropriate inspection and the expected FDA compliance program and updating the Registration & Listing regulations every 6 months by any medical device company would lead to many complicated penalties including a device recall.
FDA compliance program stated that “manufacturers are expected to control their products from “cradle to grave” meaning from the design stage through post-market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking and Corrections and Removals regulations involved activities with which manufacturers and importers are required to comply after the devices are distributed.” (Ref. meddeviceonline website)