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Compliance In Focus
Posted by John Lehmann on Tue, Jul 10, 2012

New FDA Rule: Unique Device Identification

UDI RuleOne 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.

This proposed rule was established through a joint effort between FDA, industry, patient and consumer groups, as well as the experience from four pilot studies. The UDI system aims to:

  • Improve adverse event reporting
  • Reduce medical errors
  • Enhance analysis of approved devices
  • Standardized identifier to manage recalls

Overall, the more robust post-market analysis the UDI rule will improve patient safety. The UDI rule also involves the FDA set-up of a database which will be accessible to the public. The database will allow patients to look up information about devices.

How do you think this will affect our industry as a whole? Do you see any set-backs to making devices attributable in this manner?

Photo Credit: I am Allen


Topics: Medical Devices, Unique Device Identification, FDA


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