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Minimally Invasive Glaucoma Device Guidance Finalized

The "leap frog guidance” outlines clinical and non-clinical testing recommendations for the nascent field of minimally invasive glaucoma surgical (MIGS) devices. It closely matches a February draft guidance.

FDA is hoping to provide Manufacturers of minimally invasive glaucoma surgical (MIGS) devices with a more clear-cut path to market with a newly finalized FDA guidance document .

FDA considers the document a “leap frog guidance,” meaning it provides initial recommendations on an emerging medical device technology and may be updated as more information becomes available

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