Device Classification Finder
Your device’s FDA class — I, II, or III — determines everything downstream: which controls apply, whether you need a 510(k) clearance or a full PMA, and how much regulatory runway you’re looking at. Answer four questions about your device’s risk profile and intended use to get a classification, with the specific regulatory pathway it triggers.
Class I, II or III
Quick Questions
510(k) Guidance
Question 1
What type of medical device do you have?
21 CFR Parts 862-892
Select the primary category that best describes your device:
Choose the category that matches your device\'s primary function. If your device spans multiple categories, choose the primary intended use.