FDA or food and drug administration has developed the guidelines to help the industrial market for premarket notification about accuracy in pulse oximeter. Pulse oximeter, an electrical device which is used to measure oxygen saturation level in humans is intended to be used for non invasive measurements of the heart pulse rate as well as the oxygen saturation level. It can be very dangerous treatment if you electrical device, pulse oximeter is providing you with incorrect reading about your pulse rate and oxygen saturation level.FDA or food and drug administration department check and validate that the device is working efficiently to provide correct readings. The checking is done with scientifically proven method called spot check method as approved by FDA
Generally the company manufacturing and providing the service of pulse oximeter provide full identification with important links and documents to the FDA (food and drug administration) approval for electrical pulse oximeter. You can also get a copy of FDA 510K approval document from the seller for confirmation. Recognition of actual pulse oximeter is very necessary because it may be poorly designed and constructed and the manufacturing company may use inexpensive electrical components that will give incorrect reading and it will be highly dangerous if its being treated based upon wrong results. The approval by the FDA department ensures that the oximeter consists of accurate electrical system composed of a sensor, interface cable and good quality products after proper scientific testing, inspection and output as well as input analysis.
The FDA, food and drug administration department validates pulse oximeter by process validation (that the system is obtaining accurate results) as well as design validation (means the designed is comfortable to the user). The designing and processing validation needs can be discussed in further details in 21 CFR Part 820. Make sure to read the education guidance document available for design control. FDA guides about the cleaning process, sterilization process as well as functional process validation for both design and process validation. FDA guides to remove, inactivate, etc and clean the device based on quality control scientific tests.