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Guide

Prohibited Products Policy: Medical devices

Last updated on {publishedDate}

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In this {type}:

Overview
What is the policy?
Policy basics
Frequently asked questions
Helpful resources

Overview

Products subject to our policy on Medical Devices must also adhere to other Prohibited Products Policies including our policy on Drugs and Recalled Products or Walmart will automatically unpublish your item. 

What is the policy?

Walmart prohibits the sale of products that are or would be regulated by the Food and Drug Administration (FDA) as medical devices that require a prescription (usually Class II or Class III medical devices) or that are designed for use only by healthcare professionals in the healthcare setting. Walmart also prohibits the sale of medical device accessories that require a prescription. Some non-prescription medical devices have additional regulatory restrictions that also make them prohibited for sale on Walmart’s Marketplace. Walmart also prohibits the sale of medical devices that do not comply with the requirements of the FD&C Act and that would be considered by FDA to be adulterated and/or misbranded.

Additional information

Health-related advertising claims about medical devices, which includes claims in the product description, are regulated primarily by the Federal Trade Commission (FTC). Statements made about medical devices must be truthful and not misleading and must have adequate substantiation by competent and reliable scientific evidence. FTC’s Health Products Compliance Guidance is a helpful tool for figuring out what kinds of claims and substantiation are appropriate for medical devices. In addition, the medical device must only be advertised for its intended use per FDA’s product codes and classifications. A description of a medical device that goes beyond the device’s intended use would be prohibited under Walmart’s policy.

Medical devices generally may be sold on Walmart Marketplace if they comply with:

The FD&C Act
FDA regulations and guidance regarding medical devices,
State and local laws and regulations, and Relevant laws and guidance implemented by the FTC.

Policy basics

Prohibited	Allowed with Restriction	Allowed
Medical devices that require a prescription or a medical professional's supervision, guidance, or direction for their use Accessories to high-risk medical devices (Class II or III) requiring a prescription or that are solely used by health care professionals in the health care setting Class I, II, or III medical devices that are not exempt and are required to be approved or cleared by FDA, but that have not received such approval or clearance Medical devices that do not comply with the FD&C Act, and the FDA’s implementing regulations and guidance Medical devices that are marketed for a use outside the 510(k)-cleared intended use Medical devices that are adulterated or misbranded under the FD&C Act Medical devices not packaged, labeled, or intended for individual retail sale in the U.S. Medical devices not in their original retail packaging and/or whose packaging has been opened or damaged Medical devices that are used or were refurbished Substance and surface drug test kits Contact lenses Medical devices that are subject to regulatory action or other enforcement Medical devices not manufactured in an FDA-registered facility Medical devices not manufactured in accordance with medical device Quality System Regulation (QSR) requirements, when required Medical devices not listed with FDA Medical devices named in an FDA Recalls, Market Withdrawals, & Safety Alerts Medical devices identified in FDA Warning Letters or manufactured at facilities identified in an FDA Warning Letter Medical devices alleged or determined by the FTC to have made false, misleading, or unsubstantiated claims, and those claims are still being made Medical devices that are subject to state or local regulations restricting age or quantity or that otherwise require retailer registration/reporting of the sale Medical devices or advertisements or descriptions using FDA logos or other imagery Any other medical device products that Walmart has determined must be prohibited under this policy (e.g., ear candles) Other Prohibited Products: Pill/Tablet press machines All products that are prohibited for sale under Walmart’s prohibited product policies on dietary supplements and drugs and drug paraphernalia	Certain accessories for medical devices that do not require a prescription or are suitable for consumer use outside of the health care setting. (e.g., bottles, applicators, tubes, device cleaners) Test kits that are cleared or authorized by FDA for at-home use or at-home sample collection, and that are labeled appropriately Medical devices claiming to be “FDA Approved” or “FDA Cleared” such statement is truthful and not misleading and can be adequately substantiated Certain OTC medical devices with pre-approval (e.g., hearing aids, blood glucose test strips, etc.)	Medical devices that are Class I exempt and that are intended for general consumer retail product use (e.g., tongue depressors, bedpans, toothbrushes) Medical devices that are cleared by FDA for OTC use, that are not otherwise restricted by state or local laws, and that are described and labeled in compliance with all U.S. laws and regulations.

Prohibited

Allowed with Restriction

Allowed

Medical devices that require a prescription or a medical professional's supervision, guidance, or direction for their use

Accessories to high-risk medical devices (Class II or III) requiring a prescription or that are solely used by health care professionals in the health care setting
Class I, II, or III medical devices that are not exempt and are required to be approved or cleared by FDA, but that have not received such approval or clearance
Medical devices that do not comply with the FD&C Act, and the FDA’s implementing regulations and guidance
Medical devices that are marketed for a use outside the 510(k)-cleared intended use
Medical devices that are adulterated or misbranded under the FD&C Act
Medical devices not packaged, labeled, or intended for individual retail sale in the U.S.
Medical devices not in their original retail packaging and/or whose packaging has been opened or damaged
Medical devices that are used or were refurbished
Substance and surface drug test kits
Contact lenses
Medical devices that are subject to regulatory action or other enforcement
Medical devices not manufactured in an FDA-registered facility
Medical devices not manufactured in accordance with medical device Quality System Regulation (QSR) requirements, when required
Medical devices not listed with FDA
Medical devices named in an FDA Recalls, Market Withdrawals, & Safety Alerts
Medical devices identified in FDA Warning Letters or manufactured at facilities identified in an FDA Warning Letter
Medical devices alleged or determined by the FTC to have made false, misleading, or unsubstantiated claims, and those claims are still being made
Medical devices that are subject to state or local regulations restricting age or quantity or that otherwise require retailer registration/reporting of the sale
Medical devices or advertisements or descriptions using FDA logos or other imagery
Any other medical device products that Walmart has determined must be prohibited under this policy (e.g., ear candles) Other Prohibited Products:

Pill/Tablet press machines
All products that are prohibited for sale under Walmart’s prohibited product policies on dietary supplements and drugs and drug paraphernalia

Certain accessories for medical devices that do not require a prescription or are suitable for consumer use outside of the health care setting. (e.g., bottles, applicators, tubes, device cleaners)
Test kits that are cleared or authorized by FDA for at-home use or at-home sample collection, and that are labeled appropriately
Medical devices claiming to be “FDA Approved” or “FDA Cleared” such statement is truthful and not misleading and can be adequately substantiated
Certain OTC medical devices with pre-approval (e.g., hearing aids, blood glucose test strips, etc.)

Medical devices that are Class I exempt and that are intended for general consumer retail product use (e.g., tongue depressors, bedpans, toothbrushes)
Medical devices that are cleared by FDA for OTC use, that are not otherwise restricted by state or local laws, and that are described and labeled in compliance with all U.S. laws and regulations.

Frequently asked questions

What is a medical device?

Medical devices are regulated in the United States by the U.S. Food and Drug Administration (FDA).FDA regulates a wide range of medical devices, including hip implants, infusion pumps, ventilators, breast implants, diagnostic tests (pregnancy tests, blood glucose tests, etc.) and simple devices such as tongue depressors, thermometers, and bandages. Medical Devices sold on Walmart’s Marketplace are considered “consumer medical devices” (i.e., Class I and Class II medical devices). These devices are sold over-the-counter (OTC), which means they are not sold by prescription only or distributed and used exclusively in health care settings. Generally, no training is necessary to use an OTC medical device. Rather, these devices are sufficiently user-friendly to be used by laypersons without training. Manufacturers of OTC devices rely on labeling, design, and consumer familiarity to ensure safe and effective use. Most OTC devices are not subject to FDA’s premarket review requirements but are subject to registration and listing requirements with FDA.

How are medical devices classified?

Medical devices are assigned one of three classes based on the risks associated with the use of the device. Some lower-risk devices, such as OTC devices, may be exempt from FDA premarket review and notification requirements, but are still subject to FDA registration and listing requirements and may also be subject to FDA’s Current Good Manufacturing Practices (CGMP) requirements. The majority of products eligible to be sold on Walmart’s Marketplace are Class I exempt medical devices.

The database of Class I exempt medical devices is on FDA’s website at Medical Device Exemptions 510(k) and GMP Requirements. These items may include general consumer-use medical devices like bandages, dental floss, and teething rings. There are also a small number of Class II exempt devices.
Most Class II medical devices must be reviewed by FDA through a 510(k) clearance before they can be made available for sale in the U.S. Many of these devices are cleared for prescription-only use or use only in health care settings.
Class III medical devices must be approved by the FDA through a Premarket approval before they can be made available for sale in the U.S. Class III medical devices are highest-risk and are approved for prescription-only use or use only in health care settings.
All medical devices must be manufactured in facilities registered with FDA and must be listed with FDA (Establishment Registration & Listing). Even though Class I exempt devices do not require premarket review by FDA, they still must be listed with FDA through this process and may still be subject to CGMP requirements.