Effect of regulatory and professional guidelines on the development and marketing of a dental device: case history.
The FDA encourages organizations such as the ADA to develop voluntary standards for drugs and dental devices. The landmark process of gaining ADA approval of an oral irrigator as the first therapeutic device is described. The process was time consuming and expensive, and obligates the manufacturer to submit all future marketing and advertising claims for ADA review. The ADA should continue to ensure standardized guidelines for all product categories. Education of the dental profession and the consumer concerning the significance of the ADA seal of approval is encouraged.
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Teledyne Water Pik, Fort Collins, CO 80525.
D000571:American Dental Association; D003742:Dental Devices, Home Care / Q000592:standards*; D004867:Equipment Design; D004869:Equipment Safety; D017408:Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*