D.C. Municipal Regulations (Last Updated: September 13, 2017) |
Title 22. HEALTH |
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
Chapter 22-B102. LICENSING OF MEDICAL DEVICES - DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS |
Section 22-B10209. ADVERTISING
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10209.1An advertisement of a device shall be deemed to be false if it is misleading in any particular.
10209.2An advertisement of a device is false if the advertisement represents that the device affects:
(a) Infectious and parasitic diseases;
(b) Neoplasms;
(c) Endocrine, nutritional, and metabolic diseases and immunity disorders;
(d) Diseases of blood and blood-forming organs;
(e) Mental disorders;
(f) Diseases of the nervous system and sense organs;
(g) Diseases of the circulatory system;
(h) Diseases of the respiratory system;
(i) Diseases of the digestive system;
(j) Diseases of the genitourinary system;
(k) Complications of pregnancy, childbirth, and the puerperium;
(l) Diseases of the skin and subcutaneous tissue;
(m) Diseases of the musculoskeletal system and connective tissue;
(n) Congenital anomalies;
(o) Certain conditions originating in the perinatal period;
(p) Symptoms, signs, and ill-defined conditions; or
(q) Injury and poisoning.
10209.3Subsection 10209.2 shall not apply to an advertisement of a device if the advertisement does not violate the Act and is disseminated:
(a) To the public for self-medication and is consistent with the FDA’s labeling claims;
(b) Only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or
(c) Only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device.
10209.4Nothing in this section shall be construed as establishing any official policy of the Department concerning self-medication for a disease, other than a disease listed under § 10209.2, including any official policy that such self-medication is safe and effective.