Does my medical device qualify for the de novo pathway?
September 16, 2014
By Allison Komiyama

Representatives from the newly formed Division of Industry and Consumer Education (DICE, formerly DSMICA) state that this is the most common question they receive regarding the de novo process. Not surprisingly, the answer you’ll likely receive from DICE is: “It depends.” Prior to 1997 and the Food and Drug Administration Modernization Act (FDAMA), any new device that didn’t fall under a specific classification was deemed Class III (see Food Drug & Cosmetic Act (FD&C Act) Sections 513(a)(1)(C) and 513(f)(1)). Class III devices are considered “high risk” and therefore require the

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