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.