Regulatory News In Brief

By The Gray Sheet / “The Gray Sheet” Jan. 19, 2009, Vol. 35, No. 003
Regulatory / Word Count: 738 / Article # 01350030006

Executive Summary

UDI workshop: Planned unique device identification system is up for discussion at a Feb. 12 FDA public workshop in Gaithersburg, Md. In the Jan. 15 Federal Register notice announcing the meeting, FDA lists a set of questions it hopes to tackle at the gathering - including what types of devices should be required to be marked with bar code-like identifiers; what technologies should be employed to achieve unique device identification; and the logistical and economic impact of having to add identifiers to certain devices. The 2007 FDA Amendments Act requires FDA to develop a mandatory UDI system, but gives the agency the authority to establish alternatives and exceptions. CDRH has been in talks with manufacturers, hospitals, purchasing groups and other stakeholders for at least the past three years about developing such a system as part of its plan to improve postmarket device safety oversight (1"The Gray Sheet" Feb. 6, 2006, p. 3)