10903. PROHIBITION OF PROMOTION AND OTHER PRACTICES

10903 PROHIBITION OF PROMOTION AND OTHER PRACTICES 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). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10903