UDI: Staying
Ahead of the Curve

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The FDA’s Unique Device Identifier directive was developed to provide a means to track medical devices
to facilitate post market surveillance for adverse event and recall activities that will lead to improved
device safety.

It has been difficult to track safety issues associated with medical devices as there is no single universal
means to identify these products. Gathering the appropriate surveillance data in order to make safety
decisions is a challenge.

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