Zdrowie i gospodarka · 11/02/2000

Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; and Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Availability

The Food and Drug Administration (FDA) is announcing the availability of two draft guidance documents entitled "Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme;" and "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." These draft guidance documents are neither final, nor are they in effect at this time. The review prioritization scheme guidance document sets forth factors FDA (we) would consider in categorizing a reprocessed single-use device (SUD) as high, moderate, or low risk. The enforcement priorities guidance document sets forth our priorities for various requirements based on the risk categorization of a device.