CDRH issued draft guidance for sponsors of devices containing nitinol that specifies what information should be included in their premarket submissions.
For devices manufactured with multiple types of nitinol, the FDA recommends providing information on each type of nitinol. The recommendations are based on the time period that the device would be in contact with the human body.
The performance behavior of nitinol depends on a number of factors, including alloy composition, thermal history and surface processing. The FDA recommends including information on material composition and manufacturing parameters such as heat treatments and surface processing, among other information.
