Global Medical Device Regulatory Updates

Global Medical Device Regulatory Updates

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Stewart E.

Stewart

Proposed UDI System in the US: Global Implications?

Senior Regulatory Analyst at Emergo Group

The US FDA has proposed a Unique Device Identifier system for the US medical device market, which may impact how other market regulators interested in UDI shape their own requirements in this area.

The US Food and Drug Administration has published a proposed rule that would require medical devices marketed in the US to be assigned unique device identifiers (UDI). Setting up a UDI system would improve functions such as...

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  • July 3, 2012
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  • Audie M.

    Audie

    Audie M.

    Principal Consultant at Effective Compliance Solutions L.L.C.

    Thanks Stewart. As you and many of us know, UDI has been on the door-step for a number of years. I have attended several FDA/Industry workshops on the topic, and I agree with your thought direction here - yes this will have Global Implications.

    One can hope that there will be alignment of subsequent Global activities/requirements so that industry doesn't have to comply the US requirements and yet something different/additional from the Global community.

    I hope most manufacturers have anticipated the UDI rule and at a minimum have been discussing and anticipating development of a strategy for compliance. UDI activities and compliance will require resources and money will need to be budgeted.

    While proposed rule timelines for UDI compliance (by Class) are years out from now, for some it will take years to establish a functional/compliant UDI process.

  • David L.

    David

    David L.

    President, REGULATORY DOCTOR, FDA Expert Consultant and Speaker for Global and FDA Laws and Regulations

    It is good to see that FDA has taken an action. It is worth noting "The framework can be used at a local, national, or global level. In order to reach the goal of a global UDI System, it is critical that these systems are implemented without regional or national differences. This guidance is intended to provide a high-level conceptual view of how a global UDI System should work." See http://www.ghtf.org/documents/ahwg/AHWG-UDI-N2R3.pdf
    It is expected that FDA is more likely than not to proceed accordingly.

  • Damien M.

    Damien

    Damien M.

    Vice President, Quality and Regulatory (EU & USA) at VOLUNTIS

    Hi Stewart/all:
    How might this be interpreted for standalone MD software?
    Regards
    Damien McKeon
    Voluntis

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