The U.S. Food and Drug Administration (FDA) has finalized their guidance related to medical devices that contain nitinol, the draft of which was published on April 19, 2019. The guidance recommends that companies clarify the...more
Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more