Navigating your Medical Device Through FDA
September 30, 2014
By Allison Komiyama

So you have a medical device and want to start selling it to help human kind… oh, and maybe turn a profit! But before you can legally market in the US, you’ll likely need to navigate the FDA submission process. FDA determines the classification of medical devices in the US based on the level or risk they pose to patient or end user. Class I devices are thought to have the lowest level of risk and are often exempt from any premarket submission. Logically, regulatory control increases from Class I

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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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