Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 19

Figure 2.5
FDA classification statement. (Courtesy FDA)
applied for. In the USA, a classification panel makes the decision; the manufacturer has to put
forward a case for the classification. A subtle difference, but different nonetheless.
Let us check the FDA classification for the orthotic insert. Searching for orthotic insert will
not find anything; the results of searching for orthotic are shown in Figure 2.6 .