Ross C B
Teledyne Water Pik, Fort Collins, CO 80525.
J Public Health Dent. 1992;52(6):375-7. doi: 10.1111/j.1752-7325.1992.tb02309.x.
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.
美国食品药品监督管理局鼓励诸如美国牙科协会之类的组织制定药品和牙科器械的自愿性标准。文中描述了口腔冲洗器作为首个治疗器械获得美国牙科协会批准这一具有里程碑意义的过程。该过程耗时且昂贵，并且要求制造商将未来所有的营销和广告宣传内容提交给美国牙科协会进行审查。美国牙科协会应继续确保为所有产品类别制定标准化指南。鼓励对牙科行业和消费者开展关于美国牙科协会批准印章重要性的教育。
