Public comments sought for identifier system
The FDA is seeking public comment for the next 90 days on how the use of a unique identifier system for medical devices could improve patient safety. Among other things, the agency is hoping that a unique device identification (UDI) could have broad applications in reducing medical errors, improving the reporting of adverse events, facilitating device recalls, and improving delivery and supply chain efficiency for medical devices.
Public comments sought for identifier system
The FDA is seeking public comment for the next 90 days on how the use of a unique identifier system for medical devices could improve patient safety. Among other things, the agency is hoping that a unique device identification (UDI) could have broad applications in reducing medical errors, improving the reporting of adverse events, facilitating device recalls, and improving delivery and supply chain efficiency for medical devices. A UDI could also identify which devices are compatible, such as implanted devices being used safely during an MRI, according to the FDA. A notice will appear in the Federal Register ( http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm), and a public meeting is planned in the fall.
To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
