D.C. Mun. Regs. tit. 22, r. 22-B10599
As used in this chapter, the following terms shall have the meanings ascribed:
21 U.S.C. § 360(k) summary - a summary of any information respecting safety and effectiveness. A summary of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.
21 U.S.C. § 360(k) statement - a statement asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within thirty (30) days of a request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information.
Act - the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, 21 U.S.C. § 301, et seq.
Class III certification - a certification that the submitter as described in 21 U.S.C. § 360(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices.
Class III summary-a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems.
Classification - the term used by the Department and its classification panels to describe a device or class of devices for purposes of classifying devices.
Commercial distribution - any distribution of a device intended for human use which is held or offered for sale but does not include the following:
Establishment - a place of business under one (1) management at one (1) general physical location at which a device is manufactured, assembled, or otherwise processed.
Initial importer - any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package. The term "initial importer" does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.
Manufacture, preparation, propagation, compounding, assembly, or processing of a device - the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in 21 U.S.C. § 321(h). These terms include the following activities:
Material changes - any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, intended use, contraindications, warnings, or instructions for use. Changes that are not material may include graphic layouts, grammar, or correction of typographical errors which do not change the content of the labeling of, changes in lot number, and, for devices where the biological activity or known composition differs with each lot produced, the labeling containing the actual values for each lot.
Medical device - an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:
(a) Which is:
(1) Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
(2) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
(3) Intended to affect the structure or any function of the body of man or other animals; and (b) Which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Official correspondent - person designated by the owner or operator of an establishment who is responsible for the following:
Owner or operator - the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.
Representative sampling of advertisements - typical advertising material that gives the promotional claims made for the device.
Restricted device - a device for which the Department, by regulation under § 10310 of this subtitle, or otherwise under 21 U.S.C. § 360j(e), has restricted sale, distribution, or use only upon the written or oral authorization of a practitioner licensed by law to administer or use the device or upon such other conditions as the Department may prescribe.
U.S.-designated agent - the person, residing in the United States, designated and authorized by the owner or operator of a foreign manufacturer who exports devices into the United States and is responsible for:
Vendor - any person, with the exception of an agent or sales representative of a licensed manufacturer or distributor, engaged in selling medical devices for the immediate delivery upon purchase.
Wholesale distributor - any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.
D.C. Mun. Regs. tit. 22, r. 22-B10599