FDA Releases a Proposed Rule for Medical Device Tracking System

The Food and Drug Administration (FDA) has released a proposed rule to require that most medical devices distributed in the United States carry a unique device identifier, or UDI. The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device. AMIA members interested in providing input to AMIA’s response, please contact Meryl Bloomrosen at meryl@amia.org. For more information about the proposed rule see: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm