Zdrowie i gospodarka · 20/12/2001
Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information
The Food and Drug Administration (FDA) is providing an opportunity for interested persons to submit comments and suggestions on the contents of a guidance document that FDA is considering drafting on the labeling of reprocessed single use devices (SUDs) with respect to the name of the original equipment manufacturer (OEM) and the remanufacturer (i.e., reprocessor). FDA is publishing this notice in order to gather informed comment before drafting the guidance.