U.S. Food & Drug Administration Modernization Act (FDAMA) Compliance

Simplify compliance with complete track-and-trace and e-submission capabilities

FDAMA requires manufacturers to track certain class II and class III medical devices, and submit information about the manufacturer, distributor, prescribing physician and recipient to the Food & Drug Administration in as little as three days upon request from the agency.

Beginning in 2015, FDAMA also requires Unique Device Identification (UDI) labels for class III medical devices and devices licensed under the Public Health Service Act Dates. UDIs must be in the format required for submission to the FDA GUDID database.

Complying with these FDAMA mandates will require both track-and-trace and electronic submission capabilities.

Axway 5 Suite can help.

The FDA uses Axway 5 Suite technology to manage FDAMA. For medical device manufacturers, Axway 5 Suite can help increase market share, profitability and patient safety while ensuring and simplifying compliance with current and upcoming FDAMA requirements.

How does the solution work?

Axway 5 Suite provides a foundation for a secure global distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies. To satisfy FDAMA requirements, you can use Axway 5 Suite’s Track & Trace to manage serialized and non-serialized product events, and give your internal and external trusted parties access to product identification, location, serialization and event data at any point in the delivery supply chain. Axway eSubmissions enables electronic submission of information to the FDA GUDID database.

Relevant Axway 5 Suite Products

  • Axway Track & Trace

    End-to-end transparency, logistics management and product ID verification services

    • Track devices by lot number, batch number, model number or serial number
    • Associate and manage product master data, serialized events and distribution channel events
    • Capture aggregations and change-of-ownership and de-commissioning events to provide a complete picture of the product lifecycle
    • Access a clear history of previously reported events
  • Axway eSubmissions

    Secure and efficient electronic submissions

    • Digitize the submission process
    • Format and submit UDIs as required by the FDA GUDID database
    • Secure, track, monitor and report on submissions activity
    • Simplify and lower the cost of data retention and archiving required for compliance and auditing

Supporting Resources

  • Success Story: Life Sciences

    Genzyme

    Meeting global compliance initiatives while streamlining serial number management capabilities across locations worldwide

Want to simplify FDAMA compliance?

Let’s talk.

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