Medical devices and accessories

Medical devices are regulated by the Food and Drug Administration (FDA), which is the U.S. federal agency that is responsible for ensuring that medical devices intended for human use are safe and effective. A medical device is an instrument, apparatus, machine or related object used to diagnose, cure, treat, or prevent diseases in people or animals. Medical devices can also be used to change the structure or function of the body, such as stimulating hair growth.

Some medical devices may be sold over-the-counter (OTC) to general consumers, while others are professional use and prescription only (Rx) medical devices. The FDA differentiates medical devices as OTC and Rx by assessing a device intended use and how safe it is to operate the device. FDA makes this differentiation by assessing the potential harm imposed on a patient because of the operation method of a device. Devices that are considered to be potentially harmful or unsafe unless operated under the supervision of a licensed healthcare practitioner are considered to be Rx medical devices. These products must comply with FDA’s Rx labeling requirements and they may only be sold to licensed healthcare practitioners. FDA recognizes that OTC and Rx classification can depend on a manufacturer’s intended use for the device. In these instances, the manufacturer is responsible for determining if the medical device should be sold to the general consumers (OTC) or if it can only be sold and operated by licensed healthcare practitioners (Rx).

On Amazon, only sellers participating in the Professional Health Care Program (PHC) are permitted to sell Rx medical devices.

For more information on the above content, go to the following FDA pages:

• Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices
• Labeling Requirements - Exemptions From Adequate Directions For Use

Use the checklist below to ensure that your product complies with FDA requirements and can be sold on Amazon.

Compliance Checklist for Medical Devices and Accessories

Registration, Clearance, and Approval

1. Owners or operators of facilities that are involved in the production and distribution of medical devices intended for use in the U.S. must be registered with the FDA. For more information, go to Device Registration and Listing and Classify Your Medical Device.
2. Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. Note that most Class I devices are exempt from 510(k) clearance. For more information, go to 510(k) Clearances.
3. Medical devices must not have been the subject of any unresolved FDA enforcement such as FDA warning letters. For more information, go to Warning Letters.

Labeling

All medical devices must be labeled in English with the following information:

1. The name and place of business of manufacturer, packer, or distributor, including the street address, city, state, and zip code;
2. Directions for use, including:
   
   1. Statements of all purposes for which and conditions under which the device can be used
   2. Quantity of dose for each use and usual quantities for persons of different ages and physical conditions
   3. Frequency of administration
   4. Duration of application
   5. Time of administration in relation to other factors
   6. Route or method of application
   7. Any preparation necessary for use.

   For more information, go to the U.S. Food and Drug Administration’s General Device Labeling Requirements.

Marketing

The requirements below apply to all product marketing materials, including the product detail page, product packaging, and any instructional materials or package inserts included with the product.

1. Medical devices must not make false or misleading statements.
2. Medical devices must use the claims 'FDA cleared' or ‘FDA approved’ appropriately.
3. Medical devices must not use the FDA logo.

All sellers are prohibited from listing 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.

FBA Offer Suppression Policy

Products identified as Rx medical devices are not eligible for Fulfillment by Amazon (FBA). Regulations prevent unlicensed fulfillment Centers from storing prescription medical devices. If you believe that your product has been incorrectly classified as a prescription medical device, contact Selling Partner Support to start an appeal.

Product Returns

Amazon does not accept customer returns on any Rx medical devices.

Examples of permitted listings for all sellers

Medical devices that are authorized by the FDA for over-the-counter purchase that are not otherwise restricted and are appropriately described and labeled, such as:

• Adhesive bandages
• Crutches
• Eyeglass frames
• Otoscopes
• Personal Sound Amplification Products (PSAPs)
• Sharps containers

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.

Examples of permitted listings for only for sellers participating in the Professional Health Care Program

Products that are labeled for professional or prescription use only (Rx) may only be sold by sellers participating in Amazon’s Professional Health Care Program to appropriately licensed healthcare customers with Amazon Business accounts. We are not currently accepting new seller applications for the Professional Health Care Program.

• Products that require a prescription or a medical professional’s supervision or direction for their use
• Products that are labeled for professional use only or not for retail sale
• Products that have been classified by the FDA as medical devices that require FDA clearance or approval that have not been cleared or approved by the FDA for over-the-counter use, such as:
  • Acupuncture/intradermal needles
  • Anesthetic vaporizers
  • Asthma inhalers
  • Bacteriostatic water
  • Cancer tests

    Examples of cancer tests are:

    • Cardiac monitor
    • Cavity varnish

      Examples of cavity varnish are:

      • Chin-up strip
      • Circumcision devices
      • Contact lens cases (unless cleared for over-the-counter use)
      • Contact lenses, including both cosmetic and corrective lenses.
      • Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and certain accessories

        Examples of Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories are:

        • Cranial electrotherapy stimulators
        • Defibrillators (unless approved or cleared for over-the-counter use)

          Examples of defibrillators (prescription dental devices) are:

          • Dental burs
          • Dental X-ray units
          • Denture relining, repairing, or rebasing resin, such as dental handpiece or dental drill

  • Electronic stethoscopes
  • Electrosurgical cutting and coagulation devices
  • Fetal Dopplers
  • Home HIV test kits, with the exception of the Home Access HIV-1 Test System, which has been approved for over-the-counter use by the FDA
  • Hypodermic needles and insulin injectors, such as Monoject Safety Syringes
  • Infant heel warmers
  • Implantable devices, such as pacemakers
  • Infusion pumps and their accessories (with exception of batteries, which are permitted)
  • Infusion set
  • Insulin pumps
  • Laser combs
  • Mandibular advancement devices

    Examples of mandibular advancement devices are:

    • Mesotherapy products
    • Nebulizers and their accessories, such as holding chambers
    • Oral cavity abrasive polishing agents, such as oxygen concentrators, compressors, conservers, generators, condensers and their accessories, such as Hyperbaric chambers

  • Penis enlargement devices
  • Pinhole eyewear that makes unapproved medical claims
  • Prescription eyewear
  • Polar Care Cold Therapy System products manufactured by BREG
  • Pulse oximeters. In order to be listed and sold by sellers outside of the Professional Health Care Program, pulse oximeters must be either (a) clearly labeled and consistently marketed as “for sports or aviation use only” or "not for medical use", or (b) cleared by the FDA for OTC purchase and marketed accordingly
  • Radiesse
  • Resin tooth bonding agents, such as seizure bite sticks
  • Skin glue
  • Surgical kits
  • Surgical sutures
  • Ultra sound therapy and ultra sound pain relief devices
  • Vaginal pessary devices
  • Ventilator machines
  • Ventros Immunodiagnostic, integrated, and chemistry systems

Example of Amazon Policy Restrictions

Ascensia and One Touch branded diabetic test strips are restricted to retail or a brand owner/confirmed authorized distributor offers.

Example of Amazon Jurisdictional Restrictions

You must also comply with state and local laws applicable to the jurisdiction into which your products are sold, as well as the jurisdiction from which you ship. Examples of jurisdictionally restricted products include reading eyeglasses, DNA test kits, and insulin pen needles.

Related help pages

• Cosmetics & Skin/Hair Care
• Drugs & Drug Paraphernalia
• Dietary Supplements
• Listing Restrictions

Additional useful information

• Medical Device
• Medical Device Safety: Includes FDA alerts, notices, and recall information
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• FDA list of restricted "Class I" Medical devices

Last update 04/21/2022