June 9, 2023

Examples of prohibited listings for all sellers

The following medical devices are prohibited for sale per FDA regulations:

  • Diabetic test strips that are pre-owned or test strips not authorized for sale in the U.S.
  • Products that have been altered to change the product’s performance, safety specifications, or indications of use
  • Products that the FDA has determined present an unreasonable risk of injury or illness, such as:
    • Ear candle
    • Zappers
  • Products for which a premarket notification or premarket approval is required but have not yet been FDA cleared or approved
  • Products that are not appropriately listed in the FDA’s Establishment Registration & Device Listing database
  • Products that have passed their expiration or “use by” dates
  • Products labeled as “tester”, “not for retail sale”, or “not intended for resale”
  • Products that are marketed as unapproved or unregistered medical devices, such as:
    • Psoriasis lamps
  • Certain menstrual cups, such as:
    • Monzcare R-cup and LadyCup
    • Rainbow and iCare menstrual cups
  • Products that have been the subject of criminal enforcement, injunctions, seizures, or warning letters, such as:
    • Lelo LunaBeads and Tor II
    • WaxVac Ear Cleaners
  • Products that incorporate Class IIIB lasers, such as laser light show projectors and Class IV lasers, such as industrial lasers
  • Listings claiming that a product is intended to be used for the diagnosis, cure, mitigation, treatment, or prevention of disease in humans unless the claim is cleared or approved by the FDA, or do not require such approval. For example, most Class 1 devices, such as:
    • Chelation products, including metal detection test kits
    • Advanced Formula EDTA Oral Chelation
    • AlkaLife Alkaline Drops
    • Beyond Chelation Improved
    • Bio-Chelat Heavy Metal Chelator
    • Cardio Chelate
    • Cardio Renew
    • Cardio Restore
    • Detoxamin Oral
    • Detoxamin Suppositories
    • EBN Detoxifying Bentonite Clay
    • Kelatox Suppositories
    • Keto-Plex
    • Kids Chelat Heavy Metal Chelator
    • Kids Clear Detoxifying Clay Baths
    • Miracle Mineral Solutions
    • Rife Machines
    • Sexually Transmitted Disease (STD) Test Kits
    • Testosterone test kits
  • Products that are adulterated or misbranded
  • Products that contain mercury, such as thermometers and batteries
  • Used and refurbished medical devices
  • Products that improperly claim to be “FDA Cleared”, “FDA approved” or products that include the FDA logo in associated images. For more information, go to Is It Really ‘FDA Approved’? and FDA Logo Policy.