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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B102. LICENSING OF MEDICAL DEVICES - DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS |
Section 22-B10208. MINIMUM STANDARDS FOR LICENSURE
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10208.1All medical device distributors, manufacturers, initial importers, or vendors engaged in the design, manufacture, packaging, labeling, storage, installation, servicing, and vending of medical devices shall comply with the minimum standards of this section.
10208.2For the purpose of this section, the policies described in the FDA’s Compliance Policy Guides as they apply to devices shall be the policies of the Department.
10208.3[REPEALED].
10208.4[REPEALED].
10208.5All manufacturing, assembling, packaging, packing, holding, testing, or labeling of devices by manufacturers shall take place in buildings and facilities described in §§ 10718 “Handling,” 10719 “Storage,” 10720 “Distribution,” and 10720 “Installation.”
10208.6No manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of medical devices by distributors, manufacturers, initial importers, or vendors shall be conducted in any personal residence.
10208.7Any place of business used by a distributor to store, warehouse, hold, offer, transport, or display devices shall:
(a)Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
(b)Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;
(c)Have a quarantine area for storage of devices that are outdated, damaged, deteriorated, misbranded, or adulterated;
(d)Be maintained in a clean and order condition; and
(e)Be free from infestation by insects, rodents, birds, or vermin of any kind.
10208.8All medical devices stored by distributors, manufacturers, initial importers, or vendors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the label of such medical devices.
10208.9Medical devices distributed by device distributors, manufacturers, initial importers, or vendors shall meet the labeling requirements of Chapter 103 of this subtitle.
10208.10Where District regulations conflict with device labeling or packaging exemptions adopted under the Federal Food, Drug, and Cosmetic Act, as amended, federal law or regulations shall preempt District regulations.
10208.11Reconditioned devices shall comply with the provisions of this chapter.
10208.12Medical device distributors, manufacturers, initial importers, or vendors shall meet the applicable medical device reporting requirements of Chapter 104 of this subtitle.
10208.13Devices which emit electronic product radiation and are distributed by device distributors or manufacturers shall meet the applicable requirements of Chapter 108 entitled of this subtitle.
10208.14[RESERVED]
10208.15Each medical device distributor, manufacturer, initial importer, or vendor who distributes prescription medical devices shall maintain a record for every prescription medical device, showing the identity and quantity received or manufactured and the disposition of each device.
10208.16Each medical device distributor, manufacturer, initial importer, or vendor who delivers a prescription medical device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.
10208.17All types of contact lenses are medical devices which may be sold and dispensed only by an individual or a business authorized by law to dispense contact lenses.
10208.18All types of contact lenses must be dispensed according to a prescription from the physician or optometrist who examined and fitted the contact lenses to the person’s eyes.