The FDA finally made its final unique device identifier rule this week, but the document is thousands of pages long. Jay Crowley, senior adviser of patient safety at the FDA, highlighted seven of the big changes medical device manufacturers should note from last year’s draft to the final. Here they are in laymen’s terms. 1) […]
While the FDA promised decisions on unique identifiers by the end of June, according to Modern Healthcare, it’s still under “administrative review.” The FDA has received an open letter to the Office of Management and Budget urging them to push the regulations through and to shorten its proposed seven-year time frame from the Advancing Patient […]
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
If the makers of high-risk, implantable medical devices were hoping that the U.S. Food and Drug Administration would delay how soon they would have to implement labeling and directly marking physical devices under its unique device identifier scheme, their hopes were dashed. The agency announced Wednesday that it was amending its proposed rule regarding the […]
UDI is the missing link to protect patient safety. Tracking medical devices electronically in the supply chain will improve product recalls and adverse event reporting. Premier has these suggestions for getting the system right.