Answer :
Final answer:
Before being marketed, new dental materials must undergo rigorous evaluation, including toxicity testing, large-scale experiments, and an approval process led by the U.S. Food and Drug Administration (FDA). The evaluation process includes human subject clinical trials and data collection on safety and effectiveness.
Explanation:
New dental materials, similar to new drugs and treatments, must undergo extensive evaluation before they can be marketed. This includes an in-depth process of testing for toxicity, conducting large-scale experiments, and seeking approval from a specific regulatory body. In the United States, all such processes are supervised by the Food and Drug Administration (FDA).
Once a dental material has been adequately developed and tested, an application must be submitted to the FDA's Center for Drug Evaluation and Research (CDER). If the application passes a review period, clinical trials involving human subjects can commence. During these trials, data is collected on the material's safety and effectiveness. If the dental material meets the FDA's standards, a New Drug Application (NDA) is submitted, outlining how the material will be manufactured, packaged, and administered.
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