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    " Frequently Asked Questions "

    A medical device is an instrument, apparatus, implement,
    contrivance, implant, in vitro
    reagent, or other similar or re
    lated article, including any com
    ponent, part, or accessory, which
    recognized in the official National Formulary,
    or the United States Pharm
    acopeia, or any
    supplement to them,
    intended for use in the diagnosis of disease or
    ther conditions, or in the cure, mitigation,
    treatment, or prevention of diseas
    e, in ma
    n or other animals, or
    intended to affect the structur
    e or any function of the body of
    man or other anim
    als, and
    which does not achieve its primary intended purpo
    ses through chemical action within or on the
    body of m
    an or other animals and which is no
    t dependent upon being metabolized for the
    achievement of its primary intende
    d purposes (21 U.S.C. 321(h)).
    How does FDA classify medical devices?
    In acco
    rdance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices
    into one of three regulatory classes b
    ased on the le
    vel of control necessary to ensure safety and
    effectiveness of the device. Classification is risk
    based, that is, the risk the device poses to the
    patient and/or the user is a major factor in determining the class to which it is assigned.
    Devices in all three classes are su
    bject to general controls which re
    quire, in part, that comp
    (1) register their establishments and list th
    e medical devices they market with FDA; (2)
    manufacture their devices in accordance with G
    ood Manufacturing Practices
    ; and (3) label their
    devices in accordance with labeling regulations.
    Class I devices
    are subject only to general
    controls. They typically p
    resent the lowest potential
    for harm and are simpler in design than Class II
    or Class III devices. Examples of Class I
    devices include elastic bandages, examination
    gloves, and hand-held surgical instruments.
    Class II devices
    are those for which general controls
    alone are insufficient to provid
    e a
    reasonable assurance of safety and effectiveness.
    In addition to complying with general controls,
    Class II devices are also subject to special cont
    rols identified by the agency, which may include
    special labeling requirements, performance standards and postmarket surveillance. Examples of
    Class II devices include powered wheelchairs,
    infusion pumps, and surgical drapes.
    Class III devices
    lly are those for which insufficient information exists to determine that
    general or special controls are sufficient to
    provide a reasonable assurance of safety and
    effectiveness. Examples of Class III devices incl
    ude replacement heart valves, silicone gel-filled
    breast implants, and implante
    d cerebellar stimulators.
    Examples of medical devices incl
    ude surgical lasers, wheelchairs,
    sutures, pacema
    kers, vascular
    grafts, intraocular lenses, and ort
    hopedic pins. A longer list of exam
    ples of medical devices is in
    the FDA Information Sheet Guidance, “Significa
    nt Risk vs. Non-Significant Risk Devices.”
    Medical devices also include diagnostic products
    . Examples of diagnostics include in vitro
    diagnostic reagents and test kits
    such as pregnancy test kits, and im
    aging systems such as
    magnetic resonance imaging (MRI).
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