The widespread use of nitinol in medical devices has afforded patients a range of implants with remarkable elasticity. However, the U.S. FDA draft guidance regarding technical considerations for the use of nitinol in these devices drew a substantial amount of commentary on several points. Among the issues cited by multiple stakeholders was the description of requirements for testing for pitting and for transformation temperatures, suggesting the agency will have to revisit this draft extensively before the final form will be available to manufacturers of stents and artificial valve devices.