Author: Allison Komiyama

23bc59c40bd0a7f0ec7b186f05d9cec7
April 18, 2023
By Allison Komiyama

cc3e8e6e080ce4f4c244df48d353b032

23bc59c40bd0a7f0ec7b186f05d9cec7
April 18, 2023
By Allison Komiyama

cc3e8e6e080ce4f4c244df48d353b032

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