Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot: [11]
• Commercialize an investigational device by charging the subjects or investigators a higher price than that necessary to recover costs of manufacture, research, development, and handling.
• Unduly prolong an investigation. If data developed by the investigation indicate that premarket approval (PMA) cannot be justified, the sponsor must promptly terminate the investigation.
• Represent that an investigational device is safe or effective.
However, the sponsor may advertise for research subjects to solicit their participation in a study. Appropriate advertising methods include but are not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Advertisements should be reviewed and approved by the IRB to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol. No claims should be made, either explicitly or implicitly, that the device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other device. FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process.