Zdrowie i gospodarka · 14/08/2000

FDA Announces Guidance on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals

The Food and Drug Administration (FDA) has released a guidance document outlining its priorities for regulating single-use devices reprocessed by third parties and hospitals, with a focus on premarket submission requirements based on device classification under the Code of Federal Regulations (CFR).