Zdrowie i gospodarka · 14.08.2000

Guidance for Industry on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." This guidance document finalizes the agency's policy on how it intends to regulate third parties and hospitals engaged in reprocessing single- use devices (SUD's) for reuse. This guidance document sets forth FDA's priorities for premarket submission requirements, which will be based on the device's Code of Federal Regulations (CFR) classification (i.e., class I, II, and III).