CDRH Expresses Renewed Interest In Unique Device Identifiers
This article was originally published in The Gray Sheet
Executive Summary
CDRH Director Dan Schultz says the creation of a universal identifier system that could track the distribution of individual devices is feasible, in spite of industry concerns that such a system could be too costly
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Regulatory News In Brief
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)
Regulatory News In Brief
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)
Former CDRH Director Put Problem Solving Before Data Monitoring
[Editor's Note: To mark the FDA centennial and the 30-year anniversary of the Medical Device Amendments to the Food, Drug & Cosmetic Act, "The Gray Sheet" is conducting a series of interviews looking back at the history of device regulation. Recently we sat down with John Villforth, who served as CDRH Director from 1982-1990.