Division of Clinical Research

Office of the Vice President and Innovation

The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol.

Read the guidance

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.
Categories Policies & Guidance
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