Industry Happier With FDA's Shorter List Of UDI Data Requirements
This article was originally published in The Gray Sheet
As FDA puts the finishing touches on its planned unique device identification system, it is reporting that "many fewer issues and questions now remain" regarding the expected requirements for manufacturers and distributors.
You may also be interested in...
The long-anticipated proposal maps out a unique device identifier system that FDA says will be crucial to the future of post-market safety surveillance, recall management and safety alerts. The effort also will help reduce medical errors and bring an array of other benefits, stakeholders say.
The FDA-funded effort out of the Mercy health care system, consisting of 31 hospitals and 200 outpatient facilities in Missouri, Arkansas, Oklahoma and Kansas*, is intended as a demonstration project to help troubleshoot UDIs before a mandatory nationwide system is launched. It is one of two UDI demos in the works in advance of FDA regulations.
The hoped-for regulation on FDA's unique device identification framework will not come out until the first part of 2011, but companies should start taking steps to implement UDI now, an agency official says.