The FDA published a guidance for medical devices containing nitinol
The FDA published a draft guidance titled, “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol” which highlights the technical assessments to be considered for devices containing nitinol to address potential safety problems. In particular, this guidance describes the information that is recommended to be included in the premarket submission for this type of device, in addition to the composition of the material, such as tests to assess the susceptibility to corrosion, the thermomechanical properties, the behavior under certain temperature conditions and biocompatibility.
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol