FDA recently released a draft guidance entitled "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)," which discusses the risks of transmitting various forms of transmissible spongiform encephalopathies, including Mad Cow Disease (found in cattle), scrapie (found in sheep), chronic waste disease (found in deer), and Creutzfeldt-Jakob Disease (found in humans). The guidance is applicable to all medical devices that contain or are exposed to animal-derived materials, with the exception of in vitro diagnostic devices.… Continue Reading
