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GUIDANCE DOCUMENT

Decorative, Non-corrective Contact Lenses Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers November 2006

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

On November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under section 201(h) of the Act. Because all contact lenses are now regulated as devices, including decorative, non-corrective contact lenses intended only to change the normal appearance of the eye, all contact lenses must be the subject of a cleared premarket notification (510(k)) or an approved premarket approval application (PMA) before they may be legally marketed. Additional device authorities, such as the requirement that lenses be dispensed only upon a prescription order, also apply. This guidance explains how section 520(n) affects FDA’s regulation of non-corrective contact lenses intended to change the appearance or color of a normal eye for decorative use.

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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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