Dive Brief:
- FDA proposed a reversion Wednesday to a grace period no longer than seven days for device makers to finalize Device Identifier records in the Global Unique Device Identification Database. The grace period concept was created in June 2014 so that edits or corrections to a DI record could be made after publication to GUDID but before released to the public on AccessGUDID and openFDA.
- The grace period was lengthened to 30 days in September of that year to accommodate the learning curve for users first adopting the new database. That change was meant to be temporary and FDA is now responding to database user feedback, especially from healthcare providers, which indicated 30 days is too long to wait for access to "key information" that could impact patient outcomes.
- FDA would like to implement the shortened grace period in early 2019 and created a comment docket regarding the change that will be open until Jan. 18.
Dive Insight:
Plans to mandate use of unique device identifiers (UDI) — labeling devices with a specific code to enable information sharing and track adverse events — were launched by the Food and Drug Administration Safety and Innovation Act of 2012. The actual database for bringing together all that information was further outlined in a 2014 guidance, and AccessGUDID, the public interface for obtaining relevant data, first went live in May 2015. FDA said the database is now home to nearly two million records.
While FDA was willing to cut labelers some slack at the program's outset, a note from the agency Wednesday said it now "expects that labelers have sufficient data quality controls in place to ensure that initially submitted GUDID data are complete and accurate."
The grace period for labelers begins the day after the DI record is submitted. Once the record is made public, the ability to edit becomes limited, so as not to confuse data users. But FDA said that because labelers can still "unlock" their records for some editing after the grace period closes, the extended period is not necessary.
Overall, the long-term implementation of UDIs are still a work in progress. In November, FDA effectively extended the 2020 compliance deadline for most devices, saying it would not enforce many UDI requirements until 2022. UDIs will become more central to FDA's postmarket surveillance if it can secure funding for the National Evaluation System for health Technology (NEST), which aims to beef up the agency's real-world data collection efforts.