FDA Proposes Identifier for Most Medical Devices
The Food and Drug Administration (FDA) proposed that most medical devices distributed in the U.S. carry a unique device identifier, or UDI, acting in response to congressional legislation. It said a UDI system could improve the quality of information in…
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medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA is seeking comment on the proposal for 120 days. 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.