www.fdanews.com/articles/137987-us-fda-guidance-gives-reprocessing-instructions-for-reusable-devices
US FDA Guidance Gives Reprocessing Instructions for Reusable Devices
June 29, 2011
Manufacturers of reusable devices should consider human factors when developing labeling for these devices and validate their reprocessing instructions to make sure end users can follow them, a U.S. Food and Drug Administration (FDA) draft guidance says.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor