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
-CITE- 21 CFR Sec. 807.65 -EXPCITE- Title 21 CHAPTER I SUBCHAPTER H PART 807 Subpart D -HEAD- Sec. 807.65 Exemptions for device establishments. -TEXT- 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 purposes. (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 warehousers. (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.