D.C. Mun. Regs. tit. 22, r. 22-B10208
All 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.
For 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.
All 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."
No 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.
Any place of business used by a distributor to store, warehouse, hold, offer, transport, or display devices shall:
All 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.
Medical devices distributed by device distributors, manufacturers, initial importers, or vendors shall meet the labeling requirements of Chapter 103 of this subtitle.
Where 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.
Reconditioned devices shall comply with the provisions of this chapter.
Medical device distributors, manufacturers, initial importers, or vendors shall meet the applicable medical device reporting requirements of Chapter 104 of this subtitle.
Devices 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.
Each 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.
Each 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.
All 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.
All 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.
D.C. Mun. Regs. tit. 22, r. 22-B10208