FDA Releases Medical Device Development Tool for Long Term Biostability

The FDA has added a new tool to its voluntary Medical Device Development Tool (MDDT) program: Accelerated Testing to Prove Long-Term Material Biostability.

This new tool assesses long-term hydrolytic biostability of thermoplastic polyurethane materials being considered for cardiac or neuromodulation lead insulation.

The tool is designed for materials intended to be biostable and implanted for more than 10 years and provides longevity expectations and a preconditioning method for testing performance over the entire intended service duration of the device.

Read more on this tool here.

To read the full story, click here to subscribe.

Related Topics