Tuesday, December 3, 2013
Update on US FDA Unique Device Identification Submission System
Update on US FDA Unique Device Identification Submission System-massdevice: Manufacturers with US medical device market authorization are required to submit device identification data into a Global Unique Device Identification Database (GUDID) managed by the FDA. Firms now have two options for submitting information to the GUDID: a GUDID Web Interface that requires users to set up GUDID accounts, and an HL7 SPL option for submitting device information via xml file one record at a time.