Code of Federal Regulations Title 21 Section 807.65 Subpart D

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21 CFR Sec. 807.65 Sec. 807.65 Exemptions for device establishments

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    21 CFR Sec. 807.65

    Title 21
    PART 807
    Subpart D

    Sec. 807.65 Exemptions for device establishments.

      The following classes of persons are exempt from registration in
    accordance with Sec. 807.20 under the provisions of section 510(g)
    (1), (2), and (3) of the act, or because the Commissioner has
    found, under section 510(g)(4) of the act, that such registration
    is not necessary for the protection of the public health:
      (a) A manufacturer of raw materials or components to be used in
    the manufacture or assembly of a device who would otherwise not be
    required to register under the provisions of this part.
      (b) A manufacturer of devices to be used solely for veterinary
      (c) A manufacturer of general purpose articles such as chemical
    reagents or laboratory equipment whose uses are generally known by
    persons trained in their use and which are not labeled or promoted
    for medical uses.
      (d) Licensed practitioners, including physicians, dentists, and
    optometrists, who manufacture or otherwise alter devices solely for
    use in their practice.
      (e) Pharmacies, surgical supply outlets, or other similar retail
    establishments dispensing or selling devices in the regular course
    of business at the retail level.  This exemption also applies to a
    pharmacy or other similar retail establishment that purchases a
    device for subsequent distribution under its own name, e.g., a
    properly labeled health aid such as an elastic bandage or crutch,
    indicating 'distributed by' or 'manufactured for' followed by the
    name of the pharmacy.
      (f) Persons who manufacture, prepare, propagate, compound, or
    process devices solely for use in research, teaching, or analysis
    and do not introduce such devices into commercial distribution.
      (g) Persons who handle devices but make no revisions to such
    devices or their immediate containers, such as wholesalers or
      (h) Carriers by reason of their receipt, carriage, holding or
    delivery of devices in the usual course of business as carriers.
      (i) Persons who dispense devices to the ultimate consumer or
    whose major responsibility is to render a service necessary to
    provide the consumer (i.e., patient, physician, layman, etc.) with
    a device or the benefits to be derived from the use of a device;
    for example, a hearing aid dispenser, optician, clinical
    laboratory, assembler of diagnostic X-ray systems, and personnel
    from a hospital, clinic, dental laboratory, orthotic or prosthetic
    retail facility, whose primary responsibility to the ultimate
    consumer is to dispense or provide a service through the use of a
    previously manufactured device.
Dec. 27, 1996.