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New FDA Rule: Unique Device Identification

  
  
  

One of the biggest concerns for any device on the market is the possible risk to patients and adverse events tied to the product. In order to improve the quality of information tied to specific medical devices distributed in the US, FDA released a proposed rule for devices to carry a Unique Device Identifier (UDI).  According to the press-release the code is a unique numeric of alphanumeric sequence specific to a device model and also can be tied back to a lot or batch number and expiration date. The FDA provided an example of what a UDI would look like on a medical device label.

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