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The innovation of touch-tone telephony revolutionized the telecommunications industry by replacing the traditional rotary dial with a dual-tone multi-frequency (DTMF) signaling system. This system uses a matrix-style keypad with buttons arranged in four rows and three columns, creating 12 distinct signals each assigned to a pair of frequencies. Each button press results in a simultaneous generation of two sinusoidal tones – one from a low-frequency group (697 to 941 Hz) and one from a...
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Related Experiment Video

Updated: May 7, 2026

Autonomous and Rechargeable Microneurostimulator Endoscopically Implantable into the Submucosa
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Unique device identification system. Final rule.

    Federal Register
    |September 27, 2013
    PubMed
    Summary
    This summary is machine-generated.

    The Food and Drug Administration (FDA) finalized a rule requiring a unique device identifier (UDI) on medical devices. This system enhances traceability from distribution to patient use, improving medical device safety and tracking.

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    Area of Science:

    • Regulatory Science
    • Medical Device Technology
    • Public Health Policy

    Background:

    • Current systems lack adequate mechanisms for comprehensive medical device identification throughout their lifecycle.
    • Ensuring traceability is crucial for post-market surveillance, recall management, and patient safety.
    • The need for a standardized global approach to device identification has been recognized.

    Purpose of the Study:

    • To establish a final rule for a robust medical device identification system.
    • To mandate the inclusion of a Unique Device Identifier (UDI) on medical device labels and packaging.
    • To ensure the submission of device information to the Global Unique Device Identification Database (GUDID).

    Main Methods:

    • Implementing a final rule requiring UDI on medical device labels, with specific exceptions.
    • Mandating the inclusion of UDI in both plain-text and Automatic Identification and Data Capture (AIDC) formats.
    • Requiring direct marking of UDIs on reusable and reprocessable devices.

    Main Results:

    • Establishment of a comprehensive system for identifying medical devices through distribution and use.
    • Requirement for labelers to submit device product information to the FDA's GUDID.
    • UDI implementation on device labels, packaging, and direct marking for reusable devices.

    Conclusions:

    • The final rule provides a standardized system for unique medical device identification.
    • This UDI system is expected to significantly improve device traceability, safety, and regulatory oversight.
    • The GUDID database will serve as a central repository for critical device information.