Browse Topic: Unique device identifier

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04/01/2024

September 2023 marked the 10-year anniversary of the day the FDA’s Unique Device Identification (UDI) requirement first took effect. In that time, UDI went from an idea to a framework to a law; its GUDID database now uniquely identifies and holds data on more than 4 million medical devices and is the foundation for thousands of daily lookups and transactions.

661P2-1 Cockpit Display System Interfaces, Part 2, User Interface Markup Language (UIML)

ARINC661P2-1 (Current)02/09/2024

This document defines the User Interface Markup Language (UIML) which allows developers to specify the interface, look, and behavior of any Graphical User Interface (GUI). The GUI consists of several components, from the simplest, called primitive components (such as rectangle, text, image, group), to more complex components built by the aggregation of several primitive components and by providing relational specific logic. Also defined is the execution model, which provides the rules to interpret the language so that the graphical user interface has a standardized and consistent behavior defined for any platform. Supplement 1 adds numerous additions and changes: Scripting Language Definition Creation of A661P2_StringType Addition of Color property to the Image Primitive Addition of color Standard Library. Correction of ColorMatrix Datatype Addition of Private Library schema Constraints on max array size and max string size Rectangle primitive clarification Function Library function

Airlines Electronic Engineering Committee

Radio-Frequency Identification (RFID) Improves Efficient Delivery of Healthcare Products to Where They Are Needed

TBMG-48983

09/01/2023

Product traceability is an increasingly dominant concern in healthcare, partly due to regulations like the FDA’s Unique Device Identification (UDI) Rule for medical devices and the Drug Supply Chain Security Act (DSCSA) for pharmaceutical products. Widespread disruptions since 2020 have also exposed critical supply-chain vulnerabilities caused, in part, by a lack of visibility — with negative consequences reaching all the way to the point of care, further underlining the need for change.

The Internet of Things and UDI Compliance

TBMG-25021

07/01/2016

Consider for a moment the modern automobile. A car’s computer can pinpoint for a mechanic exactly what’s going wrong, and provide a thorough history of how things have been working (or not) in recent weeks. Data networks keep tabs on recalls and alert drivers when parts need to be replaced. In some cases, operating software can be updated wirelessly to address performance or emissions issues, without the driver lifting a finger.

Smooth Compliance: Considerations for UDI Labeling Initiatives

TBMG-22788

09/01/2015

In September 2013, the FDA announced new regulations for medical device manufacturers known as UDI (Unique Device Identifier) that would require all medical devices to bear a label containing specific information by the year 2020. The regulations were designed to phase in over a seven-year period, affecting different classes of medical devices at different compliance deadlines.

The FDA’s UDI Rule is Final: What’s Next?

TBMG-18758

12/01/2013

The U.S. Food and Drug Administration (FDA) published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD, and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed. The rule was established to improve the quality of information in medical device adverse events reports and assist the FDA in determining issues with medical devices as they arise. Now that the rule has been set, medical device manufacturers need to ensure they understand the rule so they can properly comply with the regulation.

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