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Medical
Devices
FDA defines the term “medical
device” as an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory,
which is: 1) recognized in the official National Formulary, or
the U. S. Pharmacopoeia, or any supplement to them, 2) intended
for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease, in
man or other animals, or 3) intended to affect the structure or
any function of the body of man or other animals, and which does
not achieve its primary intended purposes through chemical
action within or on the body of man or other animals and which
is not dependent upon being metabolized for the achievement of
its primary intended purpose.
Medical devices include
thousands of health care products, from simple articles such as
thermometers, tongue depressors, and heating pads to
intrauterine contraceptive devices, heart pacemakers, and kidney
dialysis machines. The term devices also includes component
parts, or accessories of devices, diagnostic aids such as
reagents, antibiotic sensitivity discs, and test kits for in
vitro diagnosis of disease and other conditions. It is now
always easy to determine whether a product will be considered by
FDA to be a drug or device. CCS offers a range of medical device
consulting, submission and auditing services including:
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