In response to the scenario below, please write an opinion letter, no more than 500 words long, following the format outlined in the reading assigned in this module. You work for BlueBelleMed, a company that manufactures a variety of consumer home diagnostic products such as pregnancy tests, ovulation tests, and fertility monitors. BlueBeIlMed recently learned that one of its home pregnancy testsSimpleblue Kit Pluswas producing an unexpected number of false negative readings. Women would receive the negative reading but then continue to experience symptoms of pregnancy. They would then conrm the pregnancy with a test at their ob/gyn ofce or through a routine medical visit. BlueBelleMed is not sure what is causing the malfunctions. In general, false negatives are much more likely with home pregnancy tests than are false positives. Some percentage of false negatives result from user error, but the number of reported false negatives for Simpleblue Kit Plus signicantly exceeds the number that would be expected. Further, many of the failure reports have documented that the users avoided any of the errors that usually result in the false negatives (e.g. taking the test too early, checking test results too soon, or using diluted urine). A number of similar pregnancy tests exist on the market, and BlueBelleMed is not aware of any of them suffering similar malfunctions. Since BlueBelleMed does not yet know why some of the tests seem to be malfunctioning, it does not have any mitigation plan other than to pull the remaining products off the shelves. BlueBelleMed would rather not pull Simpleblue Kit Plus off the shelves. It is a brand-new product that provides results more quickly than other tests and is less messy. A recall would cost the company millions of dollars. It would rather invest that money in guring out why a percentage of the tests appear to have failed. You have been asked to write a short opinion letter regarding the FDA's likely response to this situation in light of its December 27, 2016 guidance document. Be sure to explain your reasoning. Remember that unur audience is made [In of business nonnlp who arr: educator] and snnhisl'iratprl but not Inoallu trained