FDA Publishes Draft Guidance on Reprocessing of Reusable Medical Devices
This post was written by Paul Sheives.
The FDA has released for public comment a draft guidance document entitled “Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The recommendations in this guidance are intended to improve the safety and effectiveness of devices with processing or reprocessing labeling. The guidance addresses such topics as FDA’s seven criteria for reprocessing instructions, validation in accordance with the Quality System Regulations, and validation of cleaning methods for reprocessed devices. FDA is accepting comments on the document until August 1, 2011.
