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The FDA proceeds with a strategy for The Reuse of Single Use Devices

Published 7/13/2000

The Food and Drug Administration (FDA) plans to have a guide in place by January 2001 for hospitals on "The Policy of the Reuse of Single Use Devices".

The strategy proposes the following:-to treat hospitals that reprocess single use devices in the same way it treats device manufactures

-to require submission of premarketing data as if reprocessors were seeking to market device for the first time

-to require reprocessors to label single use devices and provide instructions for use.