The FDA has approved the 510(k) application for the Mercy TAPE—an anthropometric-based device developed by Dr. Susan Abdel-Rahman at Children’s Mercy Hospital in Kansas City that predicts weight in children 2 months through 16 years of age. The results from the PTN study validating this device appeared in the Annals of Emergency Medicine in 2013.
Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification—also called PMN or 510(k). This step allows the FDA to review the scientific evidence generated related to safety and efficacy and determine whether the device is equivalent to an existing device. Because the Mercy TAPE is the first weight estimation device to be submitted to the FDA, the agency examined it against a standard medical scale and subsequently generated a brand new product code to classify such devices.
The 501(k) approval clears the way for the Mercy TAPE to be marketed and distributed once the commercial partner registers with the FDA. In the meantime, the ongoing Baby TAPE study is collecting the necessary anthropometric data on children under the age of 3 months, with the eventual goal of developing, designing, and validating a similar weight estimation tool for newborns and young infants. Results from this study are expected in 2016.