D.C. Mun. Regs. tit. 22, r. 22-B10902

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10902 - LABELING OF INVESTIGATIONAL DEVICES

10902.1

An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 10300), the quantity of contents, if appropriate, and the following statement:

"CAUTION--Investigational device. Limited by District of Columbia law to investigational use."

The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

10902.2

The labeling of an investigational device shall not bear any statement that is false or misleading and shall not represent that the device is safe or effective for the purposes for which it is being investigated.

10902.3

An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement:

"CAUTION--Device for investigational use in laboratory animals or other tests that do not involve human subjects.".

D.C. Mun. Regs. tit. 22, r. 22-B10902

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

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.