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AdvaMed Urges Practical Changes to FDA UDI Rule
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) commended FDA for taking a risk-based approach to implementing a unique device identification (UDI) system for medical devices but urged the agency to consider a number of changes to the agency’s proposed UDI rule to make it more practical and useful.
In comments submitted yesterday on FDA’s July 10 UDI proposed rule, AdvaMed noted its support of the agency’s goal of improving identification of medical devices used in the U.S. through an appropriate UDI system.
The Association stressed, however, that implementation of a UDI system “is a costly proposition, one that should be carefully considered such that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, health care providers, industry and the FDA.”
AdvaMed’s comments provided a number of key recommendations – taking into account the diversity of the medical technology industry – so that a final UDI rule could be implemented “in an efficient and cost-effective manner for manufacturers, device users, and the FDA.” Among the significant changes to the proposed rule suggested by AdvaMed:
- 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,” said AdvaMed President and CEO Stephen J. Ubl, “and believes that if appropriately implemented, such a system holds the promise of more accurate and consistent post-market surveillance.”
“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,” Ubl pointed out.
“FDA’s proposed rule is a good first step, “Ubl said, “and we are committed to working with FDA and other stakeholders to develop an effective UDI system that takes into account the diversity of medical devices and provides information useful to understanding their post-market performance.”
A copy of AdvaMed’s UDI comments can be obtained here.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.