Free FDA Pathway Assessment
Which submission pathway fits your device?
Answer 5 questions. Get a personalized recommendation in 60 seconds. No email required.
1 of 5. What kind of device are you developing?
2 of 5. Is there a legally marketed predicate device?
3 of 5. Do you have clinical data?
4 of 5. Has FDA reviewed similar technology before?
5 of 5. What's your target US market launch?
This is a directional guide based on common FDA decision criteria. Your actual pathway depends on full device characterization, intended use, and FDA's current thinking. Always confirm with a Pre-Submission meeting.