Classification of certain medical devices may be predisposed to ambiguities related to which classification type (I, II, or III) they belong too. The three FDA classification types for medical devices are: I – general control, II – special controls including general controls or III – premarket approval including general controls [1]. Proper definition of the classification in which the medical device belongs to is necessary for FDA compliance. In the case that the medical device has an indeterminate classification, a 513(g) can be exercised to request FDA guidance for its proper classification.
