FDA releases industry guidance for MIGS devices

The FDA has issued a final guidance document for industry and FDA staff on minimally invasive glaucoma surgical (MIGS) devices in an effort to simply the process of bringing MIGS devices to the U.S. market

This premarket study of implantable MIGS devices provides initial recommendations to support the development of premarket approval applications for MIGS devices. The guidance document includes recommendations for clinical studies (study design, subject selection factors, effectiveness endpoints and safety outcomes) as well as recommendations for nonclinical testing (biocompatibility, physical and mechanical attributes, sterility, packaging, shelf life and shipping).

A draft of this guidance was initially published in February 2015