Important: If you supply products for sale on Amazon, you must comply with all
federal, state, and local laws and Amazon policies applicable to those products and
product listings.
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.
Note: We
are currently not accepting new applications for the Professional Health Care
Program.
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
-
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).
-
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.
-
Class III medical devices must be approved by the FDA for sale in the U.S.
(for more information, see Premarket Approval (PMA)).
-
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
-
All medical devices must be labeled in English with the following
information:
-
The name and place of business of manufacturer, packer, or
distributor, including the street address, city, state, and zip
code;
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Directions for use, including:
-
Statements of all purposes for which and conditions under
which the device can be used;
-
Quantity of dose for each use and usual quantities for
persons of different ages and physical conditions;
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Frequency of administration;
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Duration of application;
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Time of administration in relation to other factors;
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Route or method of application; and
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Any preparation necessary for use.
-
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.
-
Medical devices must not make false or misleading statements.
-
Medical devices must use the claims "FDA cleared" appropriately (for more information, see
Is It Really ‘FDA
Approved?’).
-
Medical devices must not use the FDA logo or state they are "FDA approved" (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.
Note: The following listings are
prohibited for any seller not authorized to sell restricted medical products through
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:
-
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:
-
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:
-
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:
-
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
Additional useful information
Last update 04/14/2021