District of Columbia Administrative Code

10175 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10176 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10177 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10178 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10179 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10180 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10181 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10182 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10183 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10184 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10185 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10186 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10187 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10188 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10189 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10190 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10191 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10192 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10193 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10194 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10195 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10196 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10197 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10198 RESERVED SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007). AUTHORITY: DC-DCMR Section 1301 of the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code 44-101.01 et seq. (2012 Repl.)) (the “Act”), an…

10199 DEFINITIONS 10199.1 The definitions of terms provided in the Act (at D.C. Official Code § 44-102.01) shall apply to this chapter, unless provided another definition under § 10199.2. 10199.2 When used in this chapter, the following terms and phrases shall have the meanings a…

10200 GENERAL PROVISIONS 10200.1 These sections provide for the minimum licensing standards necessary to ensure the safety and efficacy of medical devices placed in the stream of commerce by distributors, manufacturers, initial importers, and vendors. SOURCE: Final Rulemaking pub…

10201 APPLICABLE LAWS AND REGULATIONS 10201.1 The Department of Health (Department or DOH) adopts by reference the following laws and regulations: (a) Federal Food, Drug, and Cosmetic Act, approve June 25, 1938, 21 U.S.C. § 301, et seq. (“act”) as amended; (b) 21 Code of Federal …

10202 EXEMPTIONS 10202.1 A person is exempt from licensing under these sections if the person engages only in the following types of device distribution: (a) Intra-company sales; or (b) The sale, purchase, or trade of a distressed or reconditioned device by a salvage operator. 10…

10203 LICENSURE REQUIREMENTS FOR DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS 10203.1 Except as provided by § 10202, a person may not engage in distributing, manufacturing, importing, or vending medical devices in the District of Columbia unless the person has a va…

10204 LICENSING PROCEDURES FOR DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS AND VENDORS 10204.1 License application forms may be obtained from the Department at 899 North Capitol Street, N.E., Washington, D.C., or online at HYPERLINK "http://www.hpla.doh.dc.gov" www.hpla.doh.dc…

10205 REPORT OF CHANGES 10205.1 The license holder shall notify the department in writing no later than ten (10) days after any change which would render the information contained in the application for the license, reported pursuant to § 10204 (relating to Licensing Procedures),…

10207 REFUSAL, CANCELLATION, SUSPENSION, OR REVOCATION OF LICENSE 10207.1 The Director may refuse an application or may refuse to license an applicant, or, suspend or revoke a license , after providing the applicant or licensee with an opportunity for a hearing, if the applicant …

10208 MINIMUM STANDARDS FOR LICENSURE 10208.1 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 stan…

10209 ADVERTISING 10209.1 An advertisement of a device shall be deemed to be false if it is misleading in any particular. 10209.2 An advertisement of a device is false if the advertisement represents that the device affects: Infectious and parasitic diseases; Neoplasms; Endocrine…

10210 ENFORCEMENT AND PENALTIES 10210.1 To enforce the provisions of this chapter, the Department, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business: (a) Enter at reasonable time…

10299 DEFINITIONS 10299.1 As used in this chapter, the following terms shall have the meanings ascribed: 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 devi…

10300 MEDICAL DEVICES: NAME AND PLACE OF BUSINESS OF MANUFACTURER, OR DISTRIBUTOR 10300.1 The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. 10300.2 The requirement for declaration of the n…

10301 MEANING OF “INTENDED USES” 10301.1 The words “intended uses” or words of similar import in §§ 10302, 10312, and 10314 of this chapter refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons’ expr…

10302 RESERVED SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10302 AUTHORITY: DC-DCMR Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 198…

10303 MEDICAL DEVICES: MISLEADING STATEMENTS 10303.1 Among representations in the labeling of a device which render the device misbranded is a false or misleading representation with respect to another device, drug, food, or cosmetic. SOURCE: Final Rulemaking published at 60 DCR …

10304 MEDICAL DEVICES: PROMINENCE OF REQUIRED LABEL STATEMENTS 10304.1 A word, statement, or other information required by or under the authority of the Act to appear on the label may lack prominence and conspicuousness, for the following: Such word, statement, or information fai…

10305 MEDICAL DEVICES: SPANISH LANGUAGE VERSION OF CERTAIN REQUIRED STATEMENTS 10305.1 If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, the labeling is autho…

10306 PRINCIPAL DISPLAY PANEL 10306.1 The term “principal display panel” as it applies to over-the-counter devices in package form and as used in this part means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of d…

10307 STATEMENT OF IDENTITY 10307.1 The principal display panel of an over-the-counter device in package form shall bear as one (1) of its principal features a statement of the identity of the commodity. 10307.2 The statement of identity shall be in terms of the common name of th…

10308 DECLARATION OF NET QUANTITY OF CONTENTS 10308.1 The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in terms of weight, measure, numerical count, or a combination of numerical count and we…

10309 MEDICAL DEVICES: WARNING STATEMENTS FOR DEVICES CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS AND OTHER CLASS I OZONE-DEPLETING SUBSTANCES 10309.1 All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl ch…

10310 PRESCRIPTION DEVICES 10310.1 A device which, because of any potential for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, …

10311 RETAIL EXEMPTION FOR PRESCRIPTION DEVICES 10311.1 A device subject to § 10310.1 shall be exempt at the time of delivery to the ultimate purchaser or user from 21 U.S.C. § 352(f)(1) if it is delivered by a licensed practitioner in the course of his or her professional practi…

10312 MEDICAL DEVICES HAVING COMMONLY KNOWN DIRECTIONS 10312.1 A device shall be exempt from 21 U.S.C. § 352(f)(1) insofar as adequate directions for common uses thereof are known to the ordinary individual. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Dist…

10313 IN VITRO DIAGNOSTIC PRODUCTS 10313.1 A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product shall be deemed to be in compliance with the requirements of this section if it meets the requirements of 21 C.F.R. § 809.10. SOURCE: Fina…