Progress is being made in the U.S. Food and Drug Administration’s (FDA) UDI program. Ever since Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices, the FDA has been working closely with industry, the clinical community and patient and consumer groups, and has conducted four […]
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Webcast: Jay Crowley Discusses the UDI System
Jay Crowley, Senior Advisor for Patient Safety in FDA’s Center for Devices and Radiological Health, hosts a webcast on the FDA’s Unique Device Identification System proposed regulation. The webcast describes how the anticipate the UDI system is going to work, how the UDI system will affect device manufacturers, and the products that are exempt from UDI […]
Finally, FDA Proposes UDI Ruling
The Food and Drug Administration (FDA) has released a proposed rule mandating that most medical devices distributed in the United States carry a unique device identifier, or UDI. Back in 2007, Congress passed legislation requiring the FDA to develop regulations to establish a unique device identification system for medical devices. The UDI system can help […]
Coalition Pushes for UDI Ruling
Recently, a number of physician associations, group purchasing organizations, and other groups in the healthcare industry have petitioned Senate and House committees to set defined guidelines to implement a unique device identifier system. The Advancing Patient Safety Coalition (APS) petitioned a pair of Congressional committees to include in the latest FDA user fee agreements specific […]
A New Push For UDI Labeling
A new bill has been introduced into the Senate this week to speed up tracking of medical devices. Although the Unique Device Identification (UDI) mandate was passed in 2007 and the FDA passed a rule on how to implement the mandate, the Office of Management and Budget still has not passed final approval. Since it’s […]
Implantable Chip A Possible UDI Option
An interesting option for creating a unique device identifier, or UDI, is the VeriChip microchipping system marketed by VeriTeQ. Back in 2004, the FDA approved the use of the VeriChip, a tiny implantable computer chip, for humans. The VeriChip has been in widespread use for tracking pets. With the recent breast implant scare in Europe, […]
FDA to Issue UDI and SNI Guidelines
The FDA will soon issue guidelines for marking medical devices with a Unique Device Identification (UDI) and for identifying pharmaceuticals with a Serial Number Identification (SNI). The FDA’s goal has been to improve traceability of medical devices and pharmaceuticals, but delays have left many manufacturers and distributors of these products confused as to how they […]
Latest Updates – FDA UDI
Did you take part in the recent Public Workshop on UDI, hosted by the FDA? I was planning on joining the webcast, but unfortunately missed both days. Never fear, though – a lot of the material from the Workshop has been made available for review on-line. Head over to the Workshop site here and download what […]
FDA Announces Food Tracing Pilot Studies
The FDA announced On September 6, 2011 that the IFT will conduct two pilot studies on track and trace methods for food products.
Update to the FDA’s UDI Regulation
Are you wondering what is happening to the FDA’s Unique Device Identification (UDI) regulation? Nothing is official yet, but the most recent information sheds light on an updated timeline for the FDA UDI roll out plan. The UDI standard is expected to be published in 2012. The first set of deadlines is imposed on Class III […]