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FDA releases final guidance document on guidelines for MIGS devices

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The FDA has released a final guidance document for industry and FDA staff on devices to treat glaucoma.

“Premarket studies of implantable minimally invasive glaucoma surgical (MIGS) devices” provides initial recommendations of nonclinical and clinical studies to support the development of premarket approval applications for MIGS devices, the document said.

The FDA’s guidance includes clinical study recommendations for study design, patient selection factors, endpoints and safety outcomes, as well as recommendations for nonclinical testing related to device biocompatibility, physical and mechanical attributes, sterility, packaging, shelf life and shipping.

Intended to simplify the process for bringing more treatment options for less severe glaucoma to the U.S. market, the guidelines may be updated as more information becomes available, the document said.

A draft of this guidance was published in February 2015.