Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in 801.4 of this chapter.
21 CFR § 803.3
Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute . Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part: