FDA指南：医疗护理中的医疗器械再处理——方法及说明

Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use. While FDA recognizes the critical role and responsibility of the device user community to follow the validated reprocessing instructions in the device labeling, the focus of this document is to provide guidance to medical device manufacturers in the complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended.