隐形眼镜法规:我们去了哪里?

IF 2 4区 医学 Q2 OPHTHALMOLOGY
Kayleigh M Risser, Melody Y Zhou, Karl G Koster, Felicia I Tejawinata, Xinyu Gu, Thomas L Steinemann
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引用次数: 0

摘要

摘要:食品药品管理局和联邦贸易委员会影响着隐形眼镜市场,食品药品管理局将隐形眼镜作为医疗器械进行监管,而联邦贸易委员会则规定隐形眼镜的处方和销售方式。2004 年,《隐形眼镜规则》出台,彻底改变了隐形眼镜的处方和销售方式,立法监督成为焦点。本文探讨了隐形眼镜法规在过去二十年中的演变,并讨论了允许被动验证等法规如何塑造了当前不断发展的隐形眼镜市场。我们还探讨了相关产品(装饰性 CL、人工泪液)的监管方式,并将美国与国外的监管方式进行了比较。最后,我们讨论了包括人工智能在内的未来技术进步将如何改变CL行业及其全球监管。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Contact Lens Regulation: Where Have We Been, Where are We Going?

Abstract: The Food and Drug Administration and the Federal Trade Commission influence the contact lens (CL) market, with the Food and Drug Administration regulating CLs as medical devices and the Federal Trade Commission dictating how they are prescribed and sold. Legislative oversight came to the forefront in 2004, when the Contact Lens Rule was introduced, drastically changing how CLs are prescribed and distributed. This article examines the evolution of CL regulations over the past two decades and discusses how regulation, such as allowing passive verification, has shaped the current and evolving CL market. We also explore how related products (decorative CLs, artificial tears) are regulated and compare US regulations with those abroad. Finally, we discuss how future technological advancements, including artificial intelligence, promise to change the CL industry and its regulation worldwide.

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来源期刊
CiteScore
4.50
自引率
4.30%
发文量
150
审稿时长
6-12 weeks
期刊介绍: Eye & Contact Lens: Science and Clinical Practice is the official journal of the Contact Lens Association of Ophthalmologists (CLAO), an international educational association for anterior segment research and clinical practice of interest to ophthalmologists, optometrists, and other vision care providers and researchers. Focusing especially on contact lenses, it also covers dry eye disease, MGD, infections, toxicity of drops and contact lens care solutions, topography, cornea surgery and post-operative care, optics, refractive surgery and corneal stability (eg, UV cross-linking). Peer-reviewed and published six times annually, it is a highly respected scientific journal in its field.
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