Final US FDA Guidance on Instructions and Labeling for Reprocessed Medical Devices
Friday, March 20, 2015
Source: Mass Device
The FDA has issued final guidelines governing instructions and labeling for reusable medical devices, as well as guidelines on how manufacturers should validate the instructions. The guidance recommends that devices should contain instructions that are understandable, complete and comprehensive, as well as technically attainable in the place where the device will be used. Instructions should also be reflective of a device's intended use, recommend thorough cleaning and include microbicidal processes for disinfection or sterilization.