FDA clarifies UDI policy, seeks public comment

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A new draft guidance from the Food and Drug Administration (FDA) aims to clarify some information related to directly applying Unique Device Identifiers (UDIs) to medical devices.

Because devices are often separated from their original packaging, the FDA requires a UDI to be directly marked on a device if that device is “intended to be used more than once and reprocessed before each use.” A draft guidance released back in May said that reprocessing a reusable device consists of three steps: point-of-use processing, cleaning, and disinfection or sterilization.

With this newest draft guidance, called Unique Device Identification: Direct Marking of Devices, the FDA wanted to clear up one thing: a reusable device can be cleaned for reuse, but not necessarily disinfected or sterilized, and still be considered “reprocessed.” Such a device would still need the UDI directly applied.

Loretta Chi, regulatory counsel for the FDA UDI Program, told RadiologyBusiness.com it was important to be as detailed as possible when describing this part of the UDI process.

“The many promised benefits of the UDI regulation can only be realized if devices are adequately identified through their distribution and use,” Chi said via email.

The FDA is seeking public comment on the draft guidance, looking to address two specific questions:

  • If a medical device is going to be cleaned for reuse, but not disinfected or sterilized, should that be considered “reprocessing”?
  • Would there be benefits to the public if UDIs were directly applied to medical devices that were going to be cleaned for reuse, but not disinfected or sterilized?

Comments can be made to the FDA regarding this draft guidance until September 24, 2015.