US FDA Scaling Back 30-Day Grace Period for GUDID Medical Device Data Corrections
Regulatory Updates | Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- FDA is ending an extended grace period for Global Unique Device Identification Database (GUDID) submission corrections in early 2019.
- The GUDID grace period will be reduced from 30 calendar days currently to seven days.
- The grace period allows medical device companies to edit or correct GUDID Device Identifier (DI) records following submission but before availability to the public.
Medical device regulators at the US Food and Drug Administration plans to wind down its temporary 30-day grace period in place since 2014 for medical device companies to edit Unique Device Identification (UDI) data submitted to the agency’s Global Unique Device Identification Database (GUDID).
According to a notice from FDA, the regulator intends to reinstate a seven-calendar-day grace period starting in early 2019. The grace period is available to device manufacturers new to using GUDID and that need to correct their records after submitting them to the database.
“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 (DI) record after it is published but before it is released to the public,” states the FDA notice.
How the GUDID grace period works
The FDA GUDID grace period process entails the following elements:
- Grace period begins the day after a device’s GUDID DI record is published;
- During the grace period, a device labeler may review, edit and/or correct all data element values for its GUDID DI record;
- Labelers may still market their devices in the US when utilizing the GUDID grace period option;
- Editing and correction of GUDID DI records is allowed on a more limited basis once the grace period is over and the record has become public.
Why FDA is scaling back GUDID grace period timeframes
Following the launch of GUDID, FDA had initially set the grace period for seven days in its June 2014 GUDID guidance, but soon extended that period to 30 days to accommodate first-time GUDID submitters and better manage incoming data volumes.
Now that the database has expanded to nearly two million medical device records, users including healthcare providers must wait 30 days before obtaining public data on more types of devices whose labelers utilize the GUDID grace period, which FDA argues could impact patient treatment decisions.
In addition, labelers will continue to have limited access to “unlock” GUDID DI records even after the seven-day grace period, lessening the need for longer grace period timeframes.
Emergo by UL will provide further updates on GUDID grace periods as FDA announces them.
Learn more about US FDA GUDID and UDI regulations from Emergo by UL:
- Medical device UDI consulting and training
- US FDA consulting for medical device and IVD manufacturers
- Video overview: The US FDA UDI system
- Whitepaper: Understanding the US FDA UDI regulation