• New FDA Device Guidance Aims to Protect Against Transmissible Spongiform Encephalopathies

    The public often thinks of medical devices as complicated constructs of metal, plastics and electronics, but the fact is that many medical devices are made from animal-derived materials as well. Some constitute large parts of the device, such as a bone substitute or bovine heart valve; others are smaller portions, such as a heparin coating on a device. But as a new guidance from the US Food and Drug Administration (FDA) notes, whatever portion of the device is made from...