The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that…
Reprocessing Medical Devices
AHA comments on the Environmental Protection Agency’s (EPA) proposed standards for the use of ethylene oxide (EtO) to sterilize medical devices.
AHA comments on the Remanufacturing of Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff.