CDRH Industry: FDA Final Guidance for Devices to Treat Glaucoma

Today, the FDA released the final guidance document: “Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices.” This leap frog guidance outlines the agency’s recommended non-clinical and clinical studies to support the development of premarket approval applications for MIGS devices, potentially streamlining the process for bringing more treatment options for less severe glaucoma to the U.S. market. The FDA issues leap frog guidances to provide initial recommendations for emerging medical device technologies, like MIGS devices, and may update this guidance as more information becomes available.

MIGS devices are designed to treat less severe glaucoma by reducing high eye pressure that contributes to vision loss. Glaucoma is a group of diseases that damage the patient’s optic nerve, and it is one of the leading causes of permanent vision loss and blindness. Traditional surgical treatments for glaucoma are typically used once the disease progresses to a moderate-to-severe state and significant vision loss has occurred. To date, one MIGS device has received FDA approval.

The MIGS final guidance provides details not included in the current FDA-recognized standard for implantable glaucoma devices (ANSI Z80.27) and reflects discussion from the FDA’s 2014 workshop co-sponsored with the American Glaucoma Society. The guidance includes clinical study recommendations for study design, patient selection factors, endpoints, and safety outcomes. It also has recommendations for non-clinical testing related to device biocompatibility, physical and mechanical attributes, sterility, packaging, shelf-life, and shipping. A draft of this guidance was published in February 2015.

Thank you

Food and Drug Administration
Center for Devices and Radiological Health