The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.
By Stewart Eisenhart, Emergo Group
A final rule from US regulators on Unique Device Identifier (UDI) requirements will begin taking effect by late 2013 in an effort to reduce errors caused by misidentification of medical devices.
By: Jeffrey Shuren, M.D., J.D.
Medical devices are an important part of everyday life for many people. Some are used to diagnose, others to treat patients. Some are implanted in the body. Some are used by doctors in hospitals, while others are used by patients in their home or at work.
Updated September 20, 2013, at 3:30 p.m. with comments from the Medical Device Manufacturers Assn.
The FDA’s updated labeling standard, including product and manufacturer name, expiration date, reference and lot no., bar code and details.
The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.
By Rajeev Kapoor and Chris Paddison of A.T. Kearney Compliance
By Stewart Eisenhart, Emergo Group
The International Medical Device Regulators Forum (IMDRF), formerly known as the Global Harmonization Task Force or GHTF, has published long-awaited draft recommendations for Unique Device Identification (UDI) systems (PDF) for medical devices.
The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices.
The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.
The FDA issued new timelines for its long-awaiting "unique device identifier" system for tracking and monitoring medical technology, cutting short some deadlines for implementation by as much as 5 years in order to comply with a new law.
Later this month the FDA will host a gathering of medical device and healthcare industry stakeholders for a discussion of the agency’s unique device identifier program for tracking and monitoring medical technology.
The federal watchdog agency is asking device makers, group purchasing organizations, healthcare distributors and other healthcare industry professionals to register for the 2-day conference, during which provide guidance on the program and how to comply with new rules for medical device labeling.
The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.
Medical tech industry stakeholders are showing mixed reactions to the FDA’s latest proposal for a system of unique device identifiers that can monitor medical devices for tracking and public health purposes.
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