The Unites States Food and Drug Administration (FDA) released the final rule on September 24, 2013 that requires most medical devices distributed in the United States to carry a unique device identifier (UDI). It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service Act. It has the potential to improve the quality of information in medical device adverse event reports.
In this webcast, ArisGlobal’s Regulatory Manager, Mr. Stephen Freer, will outline all the implications of this far-reaching initiative by the FDA, the possible challenges it poses and some strategies to address them.
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