Notice of Upcoming Changes to GUDID Grace Period

We continue to implement GUDID enhancements based on user feedback and program needs. We plan to make changes to GUDID to end the temporary extension to the GUDID grace period and return to the original seven (7) day grace period, scheduled to be released beginning of March 2019.

As stated in the GUDID Guidance document, the GUDID Device Identifier (DI) record grace period is seven (7) calendar days. Once the grace period passes, the record is released to the public viaAccessGUDID and openFDA. In September 2014, the grace period was temporarily extended to thirty (30) calendar days. On December 18, 2018, we issued a public notice explaining that we were planning to end this temporary extension, and we opened a docket for comments atwww.regulations.gov (docket number FDA-2018-N-4673). All comments received were in support of this change, therefore we are moving forward with reverting to the original seven-day grace period.

Below are the changes and impacts to both GUDID web application users and GUDID HL7 SPL submitters:

• 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 openFDA.
• Please review and adjust your internal DI record review and update timelines accordingly.

Related change that only impacts GUDID HL7 SPL submitters:

• Currently, the window for FDA HL7 SPL submission processing is seven (7) calendar days. (See the GUDID HL7 SPL Implementation Specification document, page 25 for details). This was initially put in place to allow adequate time for internal processing. Based on our experience to date, a seven-day processing window is no longer required. Therefore, we are changing the GUDID HL7 SPL submission processing window to three (3) calendar days.
• Please review and adjust your internal DI record submission timelines accordingly.

We will keep you apprised of the exact implementation date and any additional details as we get closer to deployment.

Meanwhile, for all questions and concerns, please contact us via the FDA UDI Help Desk.

Sincerely,
FDA UDI Team