10511. EXEMPTIONS FOR DEVICE ESTABLISHMENTS

10511 EXEMPTIONS FOR DEVICE ESTABLISHMENTS 10511.1 The following classes of persons are exempt from registration in accordance with § 10500 in accordance with the provisions of 21 U.S.C. § 360 (g)(1), (g)(2), and g(3) because such registration is not necessary for the protection of the public health. The exemptions are limited to those classes of persons located in the District as defined in the Act: 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 21 C.F.R. § 807.65; (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 making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name (for example, 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) Carriers by reason of their receipt, carriage, holding, or delivery of devices in the usual course of business as carriers; or (h) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (for example, patient, physician, and layman) 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. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10511