FDA: UDI Compliance Will Require “Quite a bit of effort”

The FDA argues that it’s more than worth it, but the agency also acknowledges that compliance with its Final Rule on UDI (Unique Device Identification) won’t be a compliance slam dunk.

Some medical device companies “have not even begun to think about” how they’ll comply with UDI,” says CDRH Senior Advisor for Patient Safety Jay Crowley in an April 30 interview with FDAnews. A final rule is expected in June.

“Now is a great time for manufacturers to start to understand the various subtleties of UDI and the UDI database,” Crowley added.

Compliance “does require quite a bit of effort for device manufacturers,” particularly those who haven’t put much time or thought into compliance, Crowley stressed.

Crowley will participate in an interactive panel discussion, “UDI Rule – What Does It Mean for You,” at the Tenth Annual Medical Device Quality Congress June 4-6 in Bethesda, Maryland. For a longer audio version of this interview, go to www.mdqc2013.com.