Your Guide to FDA Device Classification
According to the FDA’s guidelines, there are three separate classes of medical devices: Class I, II, or III. If you don’t know which class your product falls into, you risk creating a development plan that doesn’t align with FDA requirements and doesn’t properly mitigate risk.
That’s where this guide can help. It’s a one-page, easy-to-follow infographic that will lead you to the proper class for your medical device. It even tells you if you’re required to adhere to design controls and, more generally, which FDA approval path you must go down.