CDRH Industry: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Draft Guidance for Industry and FDA Staff

A draft guidance titled, "Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices" has recently been posted.  When finalized, this draft guidance document will recommend non-clinical and clinical studies to support a premarket approval (PMA) for implantable minimally-invasive glaucoma surgical (MIGS) devices.  To view the draft guidance, please see:http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm433165.pdf