FDA to End Extended GUDID Grace Period


Posted January 2, 2019

The Food and Drug Administration (FDA) intends to return to a seven-day grace period for submissions to its Global Unique Device Identification Database (GUDID) early this year. The time labelers are able to review, edit, and correct submissions to a database record before it is released to the public was extended to 30 days in 2014.

“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,” the FDA wrote in a change notice. “If the device identification data obtained from AccessGUDID is not available at the time the device is purchased, received, and used as part of healthcare delivery, this may result in delays and disruption in distribution and clinical and registry workflow, which potentially impacts care.”

The GUDID grace period was established to ensure that database entries were not “constantly changing.” The original seven-day period was temporarily extended in 2014 to accommodate new users who were learning how to use the database and assist in processing a large amount of submissions. Since then, the grace period has not been used as intended, according to the FDA, and the agency has received “frequent requests to assist labelers to correct data after the grace period, when the record has already been released to the public.”

As a result, in 2018, the FDA added a new feature to GUDID that allows device identification (DI) records to be unlocked for editing after the grace period has ended. This enhancement was intended to help fix data submission errors, the FDA wrote, and reduce the need to delay publication of DI information through an extended grace period.

The FDA has proposed ending the temporary grace period extension early this year. Comments can be submitted to the FDA at www.regulations.gov (docket number FDA-2018-N-4673) and must be received by Jan. 18.