FDA issues guidance on submissions to device identifier database

The Food and Drug Administration has released guidance to manufacturers for submissions to its Global Unique Device Identification Database (GUDID).

It deals with how to set up accounts and begin making submissions. Guidance on the device identifiers themselves will be released at a later date.  

Congress mandated the development of the Unique Device Identifier System (UDIs) in September 2013, with the first deadline for identifiers on high-risk devices coming in September.

The identifier will be a two-part code: the static DI portion and the dynamic production identifier, which will contain more specific information such as the lot/batch, serial number or expiration date. The GUDID will house the DI, along with key descriptive or "attribute" information about the device, which the device labeler is to report and update, according to an announcement.

There will be two methods of reporting, either manually, one at a time, using a web interface, or in batches with Health Level 7 (HL7) labeling through the FDA gateway, which accepts XML files.

Gregory Daniel, managing director for evidence development and innovation at the Brookings Institution's Engelberg Center for Health Care Reform, recently laid out a path to building a robust surveillance system for medical devices, but asserted that healthcare's current infrastructure is inadequate to the task.

The FDA in February published a proposed final rule requiring that device manufacturers and importers submit adverse event reports for medical devices electronically, which goes into effect in August 2015.

The FDA also reported in March that recalls of medical devices have doubled in the past decade.

To learn more:
- read the FDA announcement (.pdf)
- check out the guidance (.pdf)

Suggested Articles

Nearly 10,000 patients involved in research studies were impacted by a third-party privacy breach that may have exposed their medical diagnoses.

Veterans Health Administration medical facilities currently have a paper medical record backlog that if stacked up would be 5.15 miles high, according to the…

The Department of Health and Human Services announced proposed changes to privacy restrictions on patients' substance use treatment records.