Jun 29, 2015

New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse.

The agency’s guidance points out that its UDI rule, 21 CFR 801.25, explicitly requires directing UDI marking on devices to be reused and reprocessed before each use; however, the rule does not define the terms “intended to be used more than once” or “reprocessed,” prompting questions about adequate compliance.

To clarify this issue, the FDA has issued the new guidance to seek industry input on two key questions:

  • Should the definition of “reprocessing” in relation to direct UDI marking requirements cover device cleaning without additional disinfection and/or sterilization? (Separate FDA guidance states that device reprocessing should include three steps: point-of-use processing, cleaning and disinfection and/or sterilization.)
  • What public health benefits would be realized by requiring direct UDI marking of devices for which reprocessing instructions pertain only to cleaning, not disinfection or sterilization?

The FDA has posited that UDI marking directly on medical devices designed for reuse and reprocessing is necessary because such devices are eventually separated from their original labeling and packaging.


  • Stewart Eisenhart