FDA Issues Draft Guidance On Nitinol In Devices

As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium. The draft guide is connected to FDA’s initiative to reevaluate the effect certain device materials -- including metal, plastic, silicone, an animal-derived product or some combination of these -- have on the body...