Date of Award
Open Access Thesis
Francis G. Spinale
The Food and Drug Administration designates all medical devices into one of three general classes contingent on their intended use, indications for use, and potential risk to the user. This classification dictates the further path the device must take to be approved for the commercial market. Section 513(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(g)) is submitted in order to gain the agency’s unofficial classification and suggested regulatory requirements. The Coagulation Companion (MicroVide) is a device designed to fluorescently quantify a key enzyme involved in the coagulation cascade, plasmin, in pediatric patients. clot formation and degradation capabilities. As the device’s indication for use is based upon monitoring rather than intervention, the aim is to be sorted into Class II where the risk of injury is low. By providing detail on the composition and intended uses of the device and proof of similar devices currently marketed in the United States, the evidence supporting the desired classification is reinforced.
Lano, M. A.(2022). The Submission of a Section 513(g) Request For Information. (Master's thesis). Retrieved from https://scholarcommons.sc.edu/etd/6743