AdvaMed Suggests Changes to FDA UDI Rule

The Advanced Medical Technology Association has requested the FDA consider several changes to the agency's proposed unique device identification rule, according to a news release.


AdvaMed said the changes it is suggesting would make the rule more practical and useful.


AdvaMed said its recommendations take into account the diversity of the medical technology industry. A copy of AdvaMed's UDI comments can be viewed by clicking here (pdf). Suggestions include the following:

  • Manufacturers of Class III devices should be given two years after the final UDI rule is issued to comply with the rule's labeling requirements, instead of one year.
  • FDA should develop a specific list of devices exempt from UDI direct marking requirements, such as absorbable sutures or stents, because such devices cannot be directly marked.
  • FDA should clarify that devices manufactured before the final UDI rule's effective date but held in inventory are not subject to the rule.

"AdvaMed has long-supported establishment of a UDI system, and believes that if appropriately implemented, such a system holds the promise of more accurate and consistent post-market surveillance," said AdvaMed President and CEO Stephen J. Ubl, in the release. "However, it is important to understand that any benefit from a UDI system depends on device users consistently and effectively utilizing the system for tracking recalls, adverse event reporting, and within electronic health records."


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