# Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
> **Food and Drug Administration** · Final rule. · Published 2014-04-21 · Effective 2014-07-21 · 79 FR 22012
## Document
- **Document number:** 2014-08940
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 22012
- **CFR reference:** 21 CFR 886
- **Publication date:** 2014-04-21
- **Effective date:** 2014-07-21
- **HHS docket:** Docket No. FDA-2013-N-0069
## Abstract

The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to 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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/04/21/2014-08940/medical-devices-ophthalmic-devices-classification-of-the-eyelid-weight)
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