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GUIDANCE DOCUMENT

Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices Guidance for Industry and Food and Drug Administration Staff December 2015

Final

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document recommends non-clinical and clinical studies to support a premarket approval (PMA) for implantable minimally-invasive glaucoma surgical (MIGS) devices. Glaucoma is a progressive condition that damages the optic nerve of the eye, is commonly associated with elevated intraocular pressure, and leads to irreversible vision loss. It is the second leading cause of visual disability and blindness in the world. One in 40 adults over 40 years of age has glaucoma severe enough to cause loss of visual function.1,2 Current treatments for glaucoma are designed to reduce the intraocular pressure (IOP). Many options are available to lower the IOP including medications, laser treatments, and surgical interventions. Current surgical treatments for glaucoma are aimed at reducing intraocular pressure through the reduction of aqueous inflow or the enhancement of aqueous outflow. While trabeculectomy is the standard surgical intervention for glaucoma, it is often reserved for moderate to severe disease. During the past decade, novel medical devices, called MIGS devices, have emerged. These devices are designed to treat less severe glaucoma by enhancing physiological aqueous outflow with an approach that causes minimal tissue disruption.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.