Free tool
Is my product a medical device?
Answer five questions based on FDA intended-use principles and get an initial read on whether your product is likely regulated as a medical device — plus what to check next.
Question 1 of 5
Does your product claim to diagnose, treat, cure, mitigate or prevent a disease or medical condition?
The claim matters more than the technology. Marketing copy, labeling and app-store descriptions all count as claims.
This quiz provides an educational initial screen, not a regulatory determination. The outcome turns on your exact intended use and claims.
Primary sources
Go beyond lookup
Describe your device in plain language and get AI-assisted triage: likely classification, product codes, premarket pathway, EU MDR and UK considerations — with evidence citations and global market scoring.
Data shown on this page comes from the U.S. Food and Drug Administration's public openFDA APIs and is provided for research convenience. MedTechCompass is not affiliated with the FDA. Verify all regulatory details against the official FDA databases before relying on them.