Quick answer: Amazon treats medical devices and accessories as restricted products regulated by the FDA. Over-the-counter devices can be sold to general consumers, but prescription and professional-use devices can only be sold through Amazon’s invite-only Professional Healthcare program and cannot use FBA; Amazon disposes of prescription devices shipped through FBA at the seller’s expense. Listings may not use the FDA logo, claim “FDA approved” or “FDA cleared” without actual approval or clearance, or claim to diagnose or treat disease unless the FDA has authorized that claim. New offers must be sealed in the original manufacturer’s packaging.
Medical supplies look like ordinary household products until a listing is removed for a claim on the box or a missing label element. This guide summarizes Amazon’s medical device policy so you can tell what you can sell and how to list it.
What Counts as a Medical Device
Amazon defines a medical device as an instrument, apparatus, machine, or related object used to diagnose, cure, treat, or prevent disease in people or animals, or to change how the body works or its structure. A medical device accessory supports or enhances a device, such as blood pressure cuff sleeves, replacement electrodes, or carrying cases made for a specific device.
Who Can Sell What
| Device type | Who can buy | How it can be sold on Amazon |
|---|---|---|
| Over-the-counter (OTC) | General consumers | Standard listing, subject to the policy requirements |
| Prescription (Rx) | Licensed healthcare practitioners | Only through the invite-only Professional Healthcare program, seller-fulfilled; not eligible for FBA |
| Professional-use | Licensed healthcare practitioners | Only through the Professional Healthcare program |
Listing Requirements
Amazon requires these listing attributes for medical devices: item name, brand name, manufacturer, number of items, part number, temperature rating, and included components. Every product needs at least one compliant main image.
Claims you cannot make
Listing attributes, images, packaging, instructions, and inserts must not:
- Include the FDA logo
- Claim “FDA approved” or “FDA cleared” unless the product has official FDA approval or clearance
- Claim the product diagnoses, cures, mitigates, treats, or prevents disease unless the claim is cleared, approved, or authorized by the FDA
Offer conditions
New offers must be sealed in the original manufacturer’s packaging, and units inside a larger sealed and labeled carton cannot be sold individually.
Documents Amazon May Request
If Amazon asks, you must submit:
- Images of all sides of the product packaging, including blank sides
- Product instructions and manuals
- The full product label in English, FDA-compliant, with device name and model, the Unique Device Identifier (UDI), the name and place of business of the manufacturer, packer, or distributor, intended use, directions, safety information, lot or serial numbers, and expiration and storage information where applicable
- For distributors, images showing the device name as it appears in the manufacturer’s device listing
Amazon does not permit over-labels. Documents must be authentic, unmodified, and not computer or AI-generated, and cannot come from a temporarily suspended validation lab.
Laws That Apply
Amazon’s policy cites the Federal Food, Drug, and Cosmetic Act and FDA regulations on device labeling (21 CFR Part 801), establishment registration and device listing (Part 807), premarket notification or 510(k) (Part 807 Subpart E), premarket approval (Part 814), and De Novo classification (Part 860 Subpart D).
How to Stay Compliant
- Confirm whether your device is OTC, prescription, or professional-use before listing.
- Remove FDA logos and unsupported “approved” or “cleared” language from listings and packaging.
- Check that the label includes every element Amazon lists, including the UDI.
- Keep FDA registration and clearance records, and manufacturer documentation, ready to submit.
- Sell only sealed, original packaging as New.
Our product safety and quality service helps sellers respond to medical device compliance requests. For other restricted categories, read Amazon restricted products.
Frequently Asked Questions
Can I sell prescription medical devices on Amazon?
Only through Amazon’s invite-only Professional Healthcare program, to licensed healthcare customers, and without FBA.
Can my listing say “FDA approved”?
Only if the product has official FDA approval or clearance. Amazon prohibits the FDA logo in any case.
What happens if a prescription device is sent to FBA?
Amazon says it will dispose of the device at the seller’s expense.
What labeling does Amazon require for medical devices?
A complete English FDA-compliant label including device name and model, UDI, manufacturer or distributor details, intended use, directions, safety information, and lot or serial numbers.
Can I add my own label over the manufacturer’s?
No. Amazon does not permit over-labels on medical devices.
Get Your Medical Listings Reviewed
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Sources
- Amazon Seller Central, Medical devices and accessories
- Amazon Seller Central, Restricted products
- Amazon Seller Central, Misleading and prohibited claims
