Zdrowie i gospodarka · 2.02.2000
Draft Guidance on Reprocessing and Reuse of Single-Use Devices: Risk Categorization Scheme; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Reprocessing and Reuse of Single-Use Devices: Risk Categorization Scheme." This draft guidance is not final nor is it in effect at this time. This document is intended to provide draft guidance for categorizing the risks posed by single-use devices (SUD's) that are reprocessed and/or reused. FDA may use this scheme to set enforcement priorities for regulation of reprocessed and/or reused SUD's.