D.C. Mun. Regs. tit. 22-B, § 10903
Prohibition of Promotion and Other Practices
Effective Jul 12, 201360 DCR 10252Authority: 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).District of Columbia, Office of the Secretary
10903.1 A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
- (a) Promote or test market an investigational device, until after the Department has approved the device for commercial distribution;
- (b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling; or
- (c) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
10903.2 If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.
SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).