FDA Bill Seeks Medical Device Identifier Rule by Year’s End

An FDA user fee bill introduced by Sens. Tom Harkin (D-Iowa) and Michael Enzi (R-Wyo.) includes language that would require HHS to issue a final rule establishing a unique device identifier system for medical devices by the end of 2012. The language calls for HHS to implement the UDI system to electronically track and recall faulty medical devices "as soon as practical."

• "Senators Want Unique Medical Device Identifier Soon" (Goedert, Health Data Management, 4/19).