FDA proposes unique device identification system for medical devices – 3 July 2012

Posted on July 4, 2012. Filed under: Health Technology Assessment | Tags: , |

FDA proposes unique device identification system for medical devices – 3 July 2012

“Today, in response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.

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. The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.”

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For more information:

Proposed Rule: Unique Device Identification System

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