FDA Solicits Feedback on Grace Period Timing for GUDID Submissions

FDA Solicits Feedback on Grace Period Timing for GUDID Submissions

FDA Solicits Feedback on Grace Period Timing for GUDID Submissions Posted: 10 Jan 2019 06:22 PM PST By Rachael E. Hunt — On December 18, 2018, FDA opened a docket for public comment regarding its intention to shorten the grace period for Global Unique Device Identification Database (GUDID) submissions from thirty days to seven days.  The grace period starts when Device Identified (DI) information is first entered by a labeler ends when the DI information it is released to the public on AccessGUDID and openFDA.  During the grace period, a labeler can edit any part of the Device Identifier (DI) submission other than the publication date (i.e., the date it was first entered).  According to FDA, the grace period is intended to provide labelers a second chance to review and revise a DI record after it is published but before it becomes public. FDA’s Global Unique Device Identification Database (GUDID) guidance, issued on June 27, 2014, allows for a grace period of seven days from publication.  Shortly after FDA issued this guidance, however, FDA announced via GovDelivery that the grace period would be temporarily extended to thirty calendar days.  FDA explained that this thirty-day extension would accommodate new users beginning to learn GUDID and allow FDA additional time to manage the processing of large volume of GUDID submissions.  The extension allows for a thirty-day delay in public access to Device Identifier records.  This temporary extension is still in effect over four years later. FDA is now proposing to end the temporary extension and revert to the original grace period of seven calendar days beginning some time in 2019 [note: no specific timeline was stated in the notice].  In explaining the need to reduce the grace period back to seven days, FDA cites feedback from healthcare providers that thirty days is too long for key information on devices used in patient care to be made available for public use.  While we understand why a thirty-day grace period was necessary as industry acclimated to the new system, it seems reasonable that any required revisions to the DI can be made in seven calendar days.  This is especially true given the fact that information can be saved on the system in draft form, prior to publication, as manufacturers prepare device labels for new products.  It also seems that manufacturers and labelers, in addition to healthcare providers, have an interest in this information being made available to the public in a timely manner. Industry and other stakeholders can submit comments to the Public Docket by January 18, 2019.