Medical Device Label Scanner
Check your device label against FDA’s requirements under 21 CFR Part 801 — device identity, manufacturer information, intended use, Unique Device Identification (UDI), warnings and contraindications, and directions for use. You’ll get an instant compliance score and a cited explanation of any risk areas.
21 CFR Part 801
Instant Risk Score
UDI & Labeling Check
Question 1 of 7
Does your label state the name or identity of the device as required by FDA?