FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol.
The final guidance:
- Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol.
- Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing.
- Provides consensus standard references and terminology to aid in the characterization of nitinol.