ADVAMED QUESTIONS UDI INITIATIVE

Industry leaders remain skeptical about a proposed mandatory unique device identification (UDI) system that is part of a new postmarket transformation initiative at CDRH. The center should work to develop a UDI system so devices and the information associated with them can be tracked throughout their lifetimes, a CDRH advisory group said in a report posted to the FDA website Nov. 9.

AdvaMed President and CEO Stephen Ubl said his group supports the FDA's efforts to better integrate its premarket, postmarket and enforcement efforts and to develop performance measurements to track how the agency handles postmarket issues.

But the UDI proposal is another matter. "Due to the diverse size, materials and configuration of medical devices, we believe that a UDI affixed to all unpackaged devices is neither currently economically practical nor technologically feasible," AdvaMed's Associate Vice President for Technology and Regulatory Affairs Jeffrey Secunda said in a Nov. 9 letter to the agency.

AdvaMed endorses the voluntary use of UDI with a manufacturer identifier and product number applied to product packaging, Secunda said. The data carrier (bar code symbology) "should not be restricted to a single level of technology," he added. "An unrestricted data carrier will allow for the greatest flexibility in applying the UDI to various sizes, shapes and materials."

The CDRH Postmarket Transformation report can be viewed at www.fda.gov/cdrh/postmarket/mdpi-report-1106.html#4a (http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html#4a).

The AdvaMed letter can be viewed at www.advamed.org/publicdocs/docket_2006n_0292.pdf (http://www.advamed.org/publicdocs/docket_2006n_0292.pdf).