A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will ...
Device-specific information must be included on Medicare claims forms or patient safety will not improve, says Cybele Bjorklund, a Distinguished Visitor at the O'Neill Institute for National and ...
(Reuters) - The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor ...
The Food and Drug Administration has announced its proposal to create a unique device identification (UDI) system for medical devices, which will impact both suppliers and providers. The rule itself ...
The FDA’s device center has posted a draft guidance that addresses unique device identifier (UDI) code requirements applied to low-risk products. The select update offers enforcement discretion in ...
Every medical device has its own unique code, allowing manufacturers to keep track of their products once they enter the market. But while these codes are critical for recalling faulty devices or ...
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