FDA Proposes Medical Device Unique Device Identification System

FDA has announced it has proposed that most medical devices distributed in the United States carry a unique device identifier, according to a news release.

 

The announcement comes in response to requirements in legislation that passed Congress.

 

A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety, according to the FDA.

 

The FDA is seeking comment on the proposal for 120 days.

 

"The safety of medical devices is a top priority for the FDA, Congress, industry, and patients," said FDA Commissioner Margaret A. Hamburg, MD, in the release. "The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety."

 

With certain exceptions, under the proposed rule, a UDI would include a device identifier, which is a unique numeric or alphanumeric code specific to a device model, and a production identifier, which includes the current production information for a device.

 

The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

 

To view the proposed rule, click here (pdf).

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