Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
February 8, 2013
Last updated
February 8, 2013
Description
Document number 2013-02862. The Food and Drug Administration (FDA) is proposing to classify the eyelid weight into class II (special controls). The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). FDA is also giving notice of its intent to exempt the external eyelid weight device from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device type.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)