New FDA Medical Device Development Tool for Long-Term Biostability

A new tool has been added by the United States’ Food and Drug Administration (FDA) to its voluntary Medical Device Development Tool (MDDT) program.

Known as “Accelerated Testing to Prove Long-Term Material Biostability”, the non-clinical assessment model evaluates long-term hydrolytic biostability of thermoplastic polyurethane materials to be used in cardiac or neuromodulation lead insulation, such as in pacemakers or implanted defibrillators.

The tool is specifically designed for biostable materials intended to be implanted for 10+ years, where assessing the hydrolysis rate can be challenging. The tool also addresses:

• Longevity expectations, and
• Preconditioning methodology for performance testing over across entire device lifetime.

The MDDT program was created to support the FDA in its process of qualifying acceptable tools for innovators to use in the development and testing of medical devices.

Further information about the new Accelerated Testing to Prove Long-Term Material Biostability tool is available via the FDA website.