Answer questions about your current medical device label to find out whether it meets FDA requirements under 21 CFR Part 801 — or where it puts your product at risk.
21 CFR Part 801 Instant Risk Check Protect Your Brand
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Result
Question 1 of 7
Does your label state the name or identity of the device as required by FDA?
Question 2 of 7
Does your label include the manufacturer or distributor name and address as required by FDA?
Question 3 of 7
Does your label clearly state the intended use or indications for use as required by FDA?
Question 4 of 7
Does your label include all required warnings, precautions, and contraindications as required by FDA?
Question 5 of 7
Does your label provide adequate directions for use in the FDA-required manner?
Question 6 of 7
Does your device label carry a UDI in both human-readable and AIDC (barcode) format as required by FDA?
Question 7 of 7
Does your label correctly display the prescription or over-the-counter status as required by FDA?
Assessment Complete
Your Label Risk Report
For informational purposes only. This is a preliminary risk assessment based on your answers. Only a professional review of your actual label by a qualified FDA specialist can confirm compliance.