Hospital groups complain about the delay in rule-setting, the long implementation timetable for the unique device identifier rule, and a new database. Manufacturers of the most potentially dangerous ...

Five medical device companies and a trade association asked FDA in late November for significant clarifications and improvements to an agency draft guidance on the global unique device identification ...

PITTSBURGH--(BUSINESS WIRE)--Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated ...

Medical device makers are feeling the weight of the Food and Drug Administration’s unique device identifier regulations. Loftware and USDM Life Sciences conducted a nationwide survey that polled ...

The Food and Drug Administration is in discussions with multiple stakeholders to create a universal unique medical device identifier to be stored in electronic health records and linked to patient ...

The FDA has established a human and machine readable UDI labeling system for identifying medical devices through their distribution and use. Device labelers must also submit information about each ...

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 ...

SAN FRANCISCO--(BUSINESS WIRE)--FDB (First Databank, Inc.), the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions, announced today that ...

(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 Advancing Patient Safety Coalition, whose members include the American Hospital Association, the American Nurses Association, Premier, and VHA, urged the Food and Drug Administration (FDA) this ...