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.”
Related Articles on AdvaMed:
AdvaMed Study: MedTech Prices Remain Low
AdvaMed Names John Graham New Vice President
AdvaMed Issues Statement on House Hearing on IRS Implementation of Device Tax
