Medical devices and accessories

This help page covers medical devices and accessories. 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 (for example, to stimulate hair growth).

Some medical devices may be sold over-the-counter (OTC) to general consumers, while others are professional-use and prescription only (Rx) devices that may only be sold to licensed healthcare practitioners. On Amazon, only sellers participating in the Professional Health Care Program are permitted to sell Rx medical devices.

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.

Please 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, see Device Registration and Listing).
2. Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. (for more information, see 510(k) Clearances). Note that most Class I devices are exempt from 510(k) clearance.
3. Class III medical devices must be approved by the FDA for sale in the U.S. (for more information, see Premarket Approval (PMA)).
4. Medical devices must not have been the subject of any unresolved FDA enforcement such as FDA warning letters (for more information, see Warning Letters).

Labeling

1. 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; and
      7. Any preparation necessary for use.
2. Prescription medical devices must include an Rx statement, i.e., "Caution: Federal law restricts this device to sale by or on the order of a (Insert name of physician, dentist or other licensed practitioner”).

For more information, see the U.S. Food and Drug Administration’s Guidance on Labeling.

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 (for more information, see Is It Really ‘FDA Approved?’).
3. Medical devices must not use the FDA logo (for more information, see Is It Really ‘FDA Approved?’).

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, see: Is It Really 'FDA Approved'? and FDA Logo Policy)

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 permitting listings for sellers participating in the Professional Health Care Program

Products that are labled for prefessional or prescription use only may only be sold by Sellers participating in Amazon’s Professional Health Care Program to appropriately licensed healthcare customers who have Amazon Business accounts. We are not currently accepting new 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
    • See examples of cancer tests below.
  • Cardiac monitor
  • Cavity varnish
    • See examples of cavity varnish below.
  • 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
    • See examples of Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories below.
  • Cranial electrotherapy stimulators
  • Defibrillators (unless approved or cleared for over-the-counter use)
    • See examples of defibrillators below.
  • Prescription dental devices, such as:
    • Dental burs
    • Dental X-ray units
    • Denture relining, repairing, or rebasing resin
      • See examples of denture relining, repairing, or rebasing resin below.
    • 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:
    • Monject 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
    • See examples of insulin pumps below.
  • Laser combs
  • Mandibular advancement devices
    • See examples of mandibular advancement devices below.
  • Mesotherapy products
  • Nebulizers and their accessories, such as holding chambers
  • Oral cavity abrasive polishing agents
    • See examples of oral cavity abrasive polishing agents below.
  • Oxygen concentrators, compressors, conservers, generators, condensers and their accessories, such as:
    • Hyperbaric chambers
  • Penis enlargement devices
    • See examples of penis enlargement devices below.
  • 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
    • See examples of resin tooth bonding agents below.
  • 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

Below are examples of Rx medical devices that may only be listed by sellers participating in the Professional Health Care Program.

Cancer tests:

• PSA Prostate Specific Antigen
• High-Sensitivity CRP Home Test Kit
• Viaguard Accu-cervical Cancer Test

Cavity varnish:

• Ascent F-Coat
• Copal Varnish with Fluoride
• Fluoridex
• GC Fuji Varnish
• Gluma Desensitizer PowerGel
• MI Varnish
• Nupro
• Pulpdent Fluoride Varnish
• Vanish Varnish

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

• BiPAP Plus
• CPAP Masks
• Devilbiss Intellipap
• iDPAP Celestia CPAP Machine
• Polaris EX CPAP
• Respironics REMstar
• RPM Bilevel CPAP System

Denture relining, repairing, or rebasing resin:

• Coe Comfort
• Coe-Soft
• Coe-Soft LC

Defibrillators (not approved for over-the-counter use):

• AED OnSite
• FRx AED
• HeartStart MRx
• Lifeline AED
• Medtronic Lifepak
• MRL LifeQuest AED
• Welch Allyn AED 20
• Zoll AED Pro

Insulin pumps:

• Animas Infusion Set
• Contact Detach Infusion Set
• GenStrip Blood Glucose Test Strips sold by Shasta Technologies LLC
• Medtronic Minimed Paradigm Revel 523
• One Touch Ping Glucose Management System

Mandibular advancement devices:

• Airflow Pressure Transducer
• Dymedix Reusable Airflow/Snore Sensor
• Nose Breathe Mouthpiece for Heavy Snorer
• Quiet Night Sleep Appliance
• Removable Acrylic Herbst
• Snore Guard
• Snore Guard Advance
• Snore Hook Discluder
• Snore Sat Recorder
• Snore-Aid Max

Oral cavity abrasive polishing agents:

• Butler Calci-Flor Prophylaxis Paste
• GC MI Paste
• GC MI Paste Plus
• Gelato Prophylaxis Paste
• Enamel Pro
• Mi Paste
• MI Paste Plus
• PREVENTECH Prophylaxis Paste with Fluoride
• VOCO Paste

Penis enlargement devices:

• Bathmate Penis Enlargement Pump
• Bathmate Hydropump Hercules

Resin tooth bonding agents:

• Ascent Bond Universal Adhesive System
• Beautibond Multi
• Beautibond Multi PR Plus
• Cimara and Cimara Zircon
• GC Fuji Bond LC
• SilJet System

Examples of prohibited listings for all sellers

• 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 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 (for example, 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 (e.g., most Class 1 devices) such as:
  • Chelation products, including metal detection test kits, such as:
    • Advanced Formula EDTA Oral Chelation
    • AlkaLife Alkaline Drops
    • Beyond Chelation Improved
    • Bio-Chelat Heavy Metal Chelator
    • Cardio Chelate
    • CardioRenew
    • CardioRestor
    • 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, see: Is It Really 'FDA Approved'? and FDA Logo Policy)

Examples of Amazon policy restrictions

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

Related Amazon help pages

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

Additional useful information

• FDA Medical Device Home Page
• FDA Medical Device Safety page, which includes alerts, notices, and recall information
• Food, Drug, and Cosmetic Act
• FDA list of restricted "Class I" Medical devices

Last update 06/22/2020