Per 21CFR 820.198 (b) "When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate." I realize we can reference a previous investigation for the issue/product, but if there isn't a previous investigation, what are some reasons why an investigation would not have to be done? The company I work for manufacturers low risk medical devices and cosmetics.