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What is a Medical Device?
Amedical
deviceis
a product used for medical purposes in patients, in
diagnosis, therapy or surgery. Whereas
medicinal products achieve their principal action by
pharmacological, metabolic or immunological means.
Medical Devicesact
by other means like physical, mechanical, thermal, physico-chemical
or chemical means.
The Food and Drug Administration has recognized three classes of
medical devices based on the level of control necessary to
assure the safety and effectiveness of the device.The classification procedures are described in
the Code of Federal Regulations, Title 21.
Class I: General controls
Class I devices are subject to the least regulatory control.
Class I devices are subject to "General Controls" as are Class
II and Class III devices.General
controls include provisions that relate to adulteration;
misbranding; device registration and listing; premarket
notification; banned devices; notification, including repair,
replacement, or refund; records and reports; restricted devices;
and good manufacturing practices.Class I devices are not intended for use in
supporting or sustaining life or to be of substantial importance
in preventing impairment to human health, and they may not
present a potential unreasonable risk of illness or injury.Most Class I devices are exempt from the
premarket notification and/or good manufacturing practices
regulation.Examples
of Class I devices include elastic bandages, examination gloves,
and hand-held surgical instruments.
Class II: General controls with special controls
Class II devices are those for which general controls alone are
insufficient to assure safety and effectiveness, and existing
methods are available to provide such assurances.In addition to complying with general controls,
Class II devices are also subject to special controls.A
few Class II devices are exempt from the premarket notification.
Special controls may include special labeling requirements,
mandatory performance standards.Devices in Class II are held to
a higher level of assurance than Class I devices, and are
designed to perform as indicated without causing injury or harm
to patient or user. Examples of Class II devices include powered
wheelchairs, infusion pumps, and surgical drapes.
Class III: General controls and premarket approval
A Class III device is one for which insufficient information
exists to assure safety and effectiveness solely through the
general or special controls sufficient for Class I or Class II
devices.Such a
device needs premarket approval, a scientific review to ensure
the device's safety and effectiveness, in addition to the
general controls of Class I.Class III devices are usually those that
support or sustain human life, are of substantial importance in
preventing impairment of human health, or which present a
potential, unreasonable risk of illness or injury.Examples
of Class III devices which currently require a premarket
notification include implantable pacemaker, pulse generators,
HIV diagnostic tests, automated external defibrillators.
Medical device jobs involve calling on
surgeons, specialists or executives. These
positions require a high level of expertise
in a given area and a proven sales track
record. To get into medical device sales,
you should have an outstanding level of
sales skills. Medical device sales training
is focused on the specific product. Medical
device jobs are on the rise in today’s
employment market due to the aging
population. Most sales representatives sell
in various states and travel half their
time.
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