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Critical3-14 days
Suppression: Medical Device or Medical Claim
The listing claims the product is a medical device, makes medical treatment claims, or positions the product for medical use without proper FDA registration. Medical device claims require 510(k) clearance or PMA approval.
How to detect this suppression
Account Health > Policy Compliance or direct notification from Amazon. The listing is typically deactivated immediately when a medical claim is detected.
Fix steps
- 1Remove all language positioning the product as a medical device or for medical treatment
- 2If the product is a legitimately registered medical device with FDA clearance: upload your 510(k) clearance number and device registration documentation to Seller Central
- 3For wellness products incorrectly flagged: revise all copy to use wellness language ("supports," "promotes") rather than medical language ("treats," "diagnoses")
- 4Prepare a POA addressing the specific claim that triggered the violation
- 5Submit through Account Health
Appeal process
POA required with documentation. For legitimate medical devices, FDA clearance documentation is required. For incorrectly flagged wellness products, the revised listing with explanation typically suffices.
Expected resolution time: 3-14 days
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