Medical Device Nitinol Increases Bench Testing: Analysis

Attorney Michael Kasser (Hogan Lovells) says that the use of nitinol by medical device manufacturers “significantly increases the amount of bench testing that will be required to obtain marketing clearance.” In an online post, Kasser says a recently finalized FDA guidance on medical devices that contain nitinol details the corrosion testing that has been common FDA practice and also significantly expands the type and amount of mechanical and characterization tests that will be required.

“As these tests typically need to be performed on final, finished devices, most of the testing burden will fall on the medical device company, not the material supplier,” Kasser says. “Accordingly, use of nitinol in medical devices should be avoided unless its unique material properties (superelasticity and/or shape memory) are critical to device function.”