USA – FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections

A recent US Food and Drug Administration (FDA) notice proposed reverting to a 7-day grace period to review, edit and correct records that medical device manufacturers are required to submit to the agency’s global and publicly available unique device identification (UDI) database.

The proposal, posted late last December, responds to feedback from users of the Global Unique Device Identification Database (GUDID) after FDA’s Center for Devices and Radiological Health (CDRH) changed the original 7-day grace period to 30 days via GUDID final guidance from 2014. The temporarily changed grace period came in anticipation of a spike in submission volume and more new users learning how to use GUDID.

Medical device manufacturers and other stakeholders were encouraged to submit comments on the new proposal by 18 January to end the temporary extension of the GUDID grace period beginning in early 2019.

« We have received user feedback, particularly from healthcare providers, that 30 days is too long to wait for key information on devices used in patient care to be made available for public use, » FDA said. « In rare circumstances, records need to be corrected after submission. The GUDID grace period is intended to provide labelers a second chance to review and make edits and/or corrections to a GUDID device identifier record after it is published but before it is released to the public on AccessGUDID and openFDA, » the agency added.

The proposal speaks to issues still facing both agency staff and industry with the complex implementation of a nationwide UDI system. The agency’s plans for a phased-in UDI system implementation surfaced in 2013.

Lena Cordie, president and founder of consulting firm Qualitas Professional Services, noted in an interview with Focus that the proposal to revert to the original grace period was to be expected. Yet it was “long overdue” and the original grace period should not have been changed as the issues have lingered for years, Cordie argued…