mdi Consultants
Upcoming Changes to GUDID Grace Period!
The FDA has announced that it plans to make changes to the GUDID grace period to return to the original seven day grace period. These changes are scheduled to be released beginning in March 2019. According to the original GUDID Guidance released, the GUDID Device Identifier (DI) record grace period was seven (7) calendar days until the record is released to the public via AccessGUDID and open FDA. The grace period was temporarily extended to 30 calendar days in 2014. Since then, in December 2018, the FDA issues a public notice, opened a docket for comments, and came to the decision to revert to the original seven-day grace period.
The following changes will affect both GUDID web application users and GUDID HL7 SPL submitter:
- The seven-day grace period takes effect the day the change is implemented in Production GUDID. Note that the grace period starts the day after the GUDID DI record is ‘Published’, i.e., the day after the DI record Publish Date.
- On the day the grace period change is implemented, existing published DI records submitted prior to the change, and are within the thirty-day grace period, will be subject to the seven-day grace period. All records that have passed the seven-day grace period as of that date will be released to AccessGUDID and
- Currently, the window for FDA HL7 SPL submission processing is seven (7) calendar days. The FDA is changing this window to three (3) calendar days.
Please review and adjust your internal Device Identifier record review and update timelines accordingly. We will update you once the changes are implemented.
? For any questions bout the GUDID Program or the grace period changes or comments or your regulatory requirement feel free to contact us at info@mdiconsultants.com or use our contact form.