Lowther G E
J Am Optom Assoc. 1979 May;50(5):579-82.
In the past decade the United States Food and Drug Administration has become increasingly involved with the regulation of materials used in the practice of optometry. It is the purpose of this paper to help the practitioner understand the FDA involvement, historically and legally, organization, how one can have input into the process, the procedures for testing and approving new drugs and devices, their regulation and the advantages and disadvantages of such control.
在过去十年中，美国食品药品监督管理局越来越多地参与到验光实践中所用材料的监管工作。本文旨在帮助从业者从历史、法律、组织架构方面了解美国食品药品监督管理局的参与情况，了解如何参与该过程、新药和新设备的测试及审批程序、它们的监管情况以及这种管控的优缺点。
