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Medical
Devices
For the health and
safety of NWMarketplace users and to encourage compliance with
applicable laws, NWMarketplace has instituted several rules relating
to sales of medical devices on our site. NWMarketplace allows the
sale of professional medical devices to authorized purchasers
and sellers of medical devices must strictly follow certain
rules set out below when listing such items on NWMarketplace.
Please read all the
information below toughly before listing medical equipment and
supplies (devices). Please see the “Some Examples” for
examples of devices not permitted for sale on NWMarketplace.
Violations of this
policy may result in a range of actions, including:
Examples of Medical
Devices that are not permitted on NWMarketplace:
Contact lenses
Prescription
eyewear (vintage eyeglasses sold for collectible purposes are
permitted)
Electrical Muscle
Stimulation (EMS) units and their accessories that require a
prescription
Transcutaneous
Electrical Nerve Stimulators (TENS) machines and their accessories
that require a prescription
Oxygen
concentrators, oxygen compressors, oxygen conservers and their
accessories that require a prescription
Defibrillators that
are not approved for over-the-counter sale
Continuous Positive
Airway Pressure (CPAP), Bi-level Positive Airway (BiPAP) devices,
and Variable Positive Airway Pressure (VPAP) devices that require a
prescription
Implantable
devices, such as pacemakers, heart valves, vascular grafts,
ventricular bypass devices, and implantable infusion pumps.
Sellers may not list
medical devices on NWMarketplace that require government
authorization for distribution to third parties unless they take all
the steps outlined below to ensure that purchases are made only by
medical professionals authorized by law to purchase such items.
Additional
Information:
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Dental
Imaging and Aesthetics Equipment
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Medical Equipment
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Medical Instruments
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Medical, Specialty
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Medical Supplies & Disposables
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Other Healthcare, Life Science
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Wholesale Lots
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Imaging and Aesthetic Supplies
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The following
language must be included in the item description:
The seller's name,
city, state and telephone number;
The seller’s
business name, if applicable; and
The following
language: "The sale of this item may be subject to regulation
by the U.S. Food and Drug Administration and state and local
regulatory agencies. If so, do not buy this item unless you are an
authorized purchaser. If the item is subject to FDA regulation, I
will verify your status as an authorized purchaser of this item
before shipping of the item."
The font size of the
language required by this paragraph shall be the same size as the
other text in the item description.
Sellers who have
questions about legal obligations regarding sales of medical devices
should consult with the FDA's Center for Devices and Radiological
Health (Device Advice or Industry Support; phone: 800.638.2041;
email: dsmica@cdrh.fda.gov).
Sellers must clean
and handle all medical devices in accordance with the manufacturer's
instructions before shipping. Sellers may not list any medical device
that has been altered in any way that significantly changes the
product's performance or safety specifications. All items must be
delivered to buyers prior to a clearly marked expiration or "use
by" date.
Sellers must clearly
inform potential buyers, in the item description, if the device has
been opened or used.
In addition, users
should review the product manufacturer's website before listing or
bidding on any used medical device to obtain the latest information
about any health or safety issues relating to that product.
Hearing Aids
While these items do
not require a prescription, they are heavily regulated. All listings
of hearing aids must include the following disclaimer:
"According
to the FDA, it is in your best health interest to obtain a
professional medical evaluation before purchasing a hearing aid and
you are encouraged to do so before bidding on this item. If you
choose to not obtain a medical evaluation before purchasing this
item, I am required by law to provide to you and obtain from you a
signed written waiver of the medical evaluation, and I am required to
provide to you a copy of the User Instruction Brochure for a hearing
aid, review the contents of that brochure with you, and afford you
time to read the brochure. You must provide to me either a signed
statement from a physician or a signed waiver before I will deliver
this item to you. Upon your request, I will also provide to you a
copy of the User Instructional Brochure for the hearing aid or the
name and address of the manufacturer or distributor from whom a User
Instructional Brochure for the hearing aid can be obtained."
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