Regulatory
1. What is the FDA status, in one word: approved, cleared, granted, listed, cosmetic or supplement? 2. What are the product code and regulation, and does the FDA database show them?FDA: classify a device 3. What use does that status cover, and is anything in the marketing outside it?21 CFR 878.9
Documentation
4. Can I have the instructions for use? 5. What sterility, single-use or batch documentation exists? 6. Who manufactures the product, and where is that establishment registered? 7. What are the warranty and return terms, in writing, and who offers them?
Marketing
8. Will you give me patient-facing copy that stays within the product’s status? 9. Does your own marketing make claims I should not repeat? 10. What is your material connection to anyone recommending this product to me?FTC endorsement guides
Every product on this site is checked against this list. Its documentation panel shows which answers are in hand and which are still outstanding.
General information for licensed practices, not legal or medical advice. Sources are linked in the text.