Lack of medical device-specific information in patient claims forms impedes the government’s ability to track Medicare costs related to the replacement of defective or recalled devices, according to a ...

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...

WASHINGTON, June 18-- The office of Sen. Charles E. Grassley, R-Iowa, issued the following news release: Sens. Chuck Grassley of Iowa and Elizabeth Warren of Massachusetts sent a letter to Food and ...

The Obama Administration’s Office of Management and Budget has approved and released a long-awaited proposed rule on a unique device identification system for medical devices. The document was ...

The senators' letter expresses concern about CMS's conflicting statements and urges CMS to support the inclusion of device identifier information on the Medicare claim form in order to better track ...

FDA, in a 2013 final rule, made it a requirement that most medical devices distributed in the United States carry a UDI as a patient safety measure. Current health insurance claims forms, however, ...

A week after federal legislators and hospitals pressed the Office of Management and Budget about the release of a final unique device identification rule, the U.S. Food and Drug Administration ...

The 21st Century Cures Act, which passed in the House of Representatives July 9, includes a non-binding amendment in favor of including unique medical device identifiers in electronic health records.