A. Submission of Evidence: Evidence must be submitted pertaining to: actions, safety and efficacy; and where applicable, mechanical and physical properties. Information on acceptable standard test methods for physical properties may be obtained from the Council on Scientific Affairs. In general, the data required on physical tests will include: methods, results, names of the observers, and dates of testing.
B. Nature of Evidence: The company must provide objective data from clinical and laboratory studies demonstrating safety and effectiveness. Evaluation of a product may also be based on similarity to a previously Accepted product. Products that fall under the scope of an official ANSI/ADA Specification will be tested for compliance with the specification by the ADA laboratory. Test samples, unless otherwise indicated in the appropriate specification, will be procured on the open market at the expense of the manufacturer.
C. Supplemental Evidence: All proprietary studies for the product as well as a list of all other studies conducted using the final product must be submitted. Additionally, the ADA may, through use of its own laboratory facilities or use of other facilities, conduct any additional evaluation deemed necessary by the Council.
D. Post Marketing Surveillance: Any new information regarding safety and efficacy must be submitted as it becomes available. This evidence may be in the form of new clinical studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.
E. Renewal of Acceptance: The company may be required to submit evidence demonstrating continued acceptable clinical performance of the product. This evidence may be in the form of new clinical and/or laboratory studies, reports of adverse reactions or follow-up investigations of previously submitted clinical studies.
F. Disclosure: The company must disclose any past, present or anticipated financial arrangements between the investigators and the company, its affiliates or subsidiaries, including, but not limited to, consulting agreements, speakers' fees, grants or contracts to conduct research, or membership on the company's advisory committees including remuneration policies, or in the product that is the subject of the investigation. If the Council determines that the financial interests raise a question about the integrity of the data, the Council may take any action it deems necessary to ensure the reliability of the data, including but not limited to:
• requesting that the company submit further analyses of the data;
• requesting that the company conduct additional independent studies; and
• rejecting the data as a basis for council action.