FDA Wants Input on Details of UDI Direct Marking Draft Guidance

Thursday, June 25, 2015

Source: MD+DI

Direct marking of a device is required, according to the UDI rule, when the medical device "is intended to be used more than once and intended to be reprocessed before each use." But FDA is looking for guidance from industry on what should be considered "reprocessed" and what the definition of "intended to be used more than once" should be.

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