By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has published draft technical specifications related to its Unique Device Identification (UDI) rule finalized earlier this year.
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.
Submitting a device information record using the HL7 SP option requires firms to establish GUDID accounts and send xml files through the FDA Electronic Submissions Gateway.
US regulators also plan to add search and retrieval capabilities to the GUDID, but the database search function remains disabled until an adequate number of records are submitted.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.