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Medical Device Tracking & Traceability

    What is Medical Device Tracking?

    Medical device tracking is monitoring and tracing medical devices throughout their lifecycle. The primary goal of medical device tracking is to enhance patient safety by facilitating the identification and recall of devices that may pose a risk to patients or fail to meet regulatory standards.

    FDA Regulations and Requirements for Medical Device Tracking

    21 CFR 820.60, 65, 86; ISO 13485:2016 section 7.5.8, 7.5.9

    Overview of medical device tracking regulations

    Manufacturers of medical devices are required to register their establishments with the FDA and list their devices commercially distributed in the United States. The FDA uses this information to maintain a database of medical devices and their manufacturers, facilitating traceability and regulatory oversight.

    Obligations of persons involved in the tracking process

    ENGINEERING AND QUALITY ASSURANCE (QA) are responsible for ensuring that all parts, processes, and products requiring traceability are assigned unique part and process numbers.

    MANUFACTURING is responsible for ensuring that all parts and products requiring traceability are assigned unique lot numbers.

    QUALITY ASSURANCE will maintain all records to ensure timely retrieval of traceability documentation.

    Premarket notification submissions for tracking purposes

    Before PreMarket Notification:

    1. UDI established
    2. DHR records
    3. Risk Management

    Importance of tracking medical devices for patient safety

    It is important to track medical devices in case the device has a non comforting or default and causes harm. These devices that were made in the same lot or batch need to be recalled, with traceability these devices can be effectively recalled back to the manufacturer.

    Implementation of Medical Device Tracking System

    This is done through having an Unique Device Identifier by the manufacturer.

    Audit procedures for ensuring compliance with tracking regulations

    During an audit, an auditor will ensure compliance by making sure that there is a UDI barcode. They will also ensure that according to the risk level of the device how many parts of the device are tracked.

    Components of a Medical Device Tracking System

    Device identifier requirements

    The requirements include- unique, FDA standard format, labeling, submission to GUDID.

    Role of Distributors in Medical Device Tracking

    Distributors are required to ensure that manufacturers have a UDI and are registered with the GUDID.

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