DIRECT MARKING FOR FDA UDI COMPLIANCE

    MARKS, METHODS, AND VERIFICATION

    Uniquely identifying devices with permanent marks is a new process for many medical device manufacturers, and the pressure to meet short deadlines for permanent device marking in compliance with the FDA UDI regulation has quickly become the manufacturer’s greatest challenge. For those now under obligation to comply with FDA UDI requirements by directly marking devices, this white paper offers current FDA guidance as well as answers to the most common questions, including:

    • What is Unique Device Identification?

    • What does it mean to “permanently mark” a device?

    • Which medical devices require direct marks?

    • What are the deadlines for permanent UDI marking?

    • Does FDA require a specific marking method?

    • What can be done to ensure mark quality and compliance?

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