Global Medical Device Podcast Powered By Greenlight.guru

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program.Some highlights of this episode include:BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.ST