Section 22-B10599. DEFINITIONS

 

10599.1 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:

 

(a)Internal or interplant transfer of a device between establishments within the same parent, subsidiary, or affiliate company;

 

(b)Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under 21 U.S.C. § 360j; or

 

(c)Any distribution of a device that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under 21 U.S.C. § 360c; provided that the device is intended solely for investigational use and is not required to have an approved premarket approval application.

 

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 importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

 

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:

 

(a) Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;

 

(b)Initial importation of devices manufactured in foreign establishments;

 

(c)Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications; or

 

(d)Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications

 

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.

 

Official correspondent – person designated by the owner or operator of an establishment who is responsible for the following:

 

(a)The annual registration of the establishment;

 

(b)Contact with the Department of Health for device listing;

 

(c)Maintenance and submission of a current list of officers and directors to the Department; ; 

 

(d)The receipt of pertinent correspondence from the Department directed to and involving the owner or operator or any of the firm’s establishments; and

 

(e)The annual certification of medical device reports or forwarding the certification form to the person designated by that the firm designates as responsible for the certification.

 

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:

 

(a)Submitting medical device reporting (MDR ) reports;

 

(b)Submitting annual certifications;

 

(c)Acting as the official correspondent;

 

(d)Submitting registration information;

 

(e)Submitting device listing information; and

 

(f)Submitting premarket notifications on behalf of the foreign manufacturer.

 

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.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).