GUDID HL7 SPL Submission Processing Update

This is a notice to labelers using the HL7 SPL submission option to submit records to the GUDID.

As October 24, 2015 approaches, the FDA UDI program is receiving an unprecedented high volume of GUDID submissions.  Labelers using the HL7 SPL submission option to submit records to the GUDID have been experiencing longer-than-normal total processing times – this includes submission processing and delivery of acknowledgements (ACKs). We have made internal adjustments to our system to increase the speed of submission processing, and at the current time, the delays are significantly reduced.

Submissions are being received via the FDA’s Electronic Submission Gateway (ESG), so labelers should be receiving Acknowledgement1(ACK1) in a timely fashion even when a large number of submissions are being received. However, if the volume gets too high, submissions will be queued for processing, so labelers may experience delays in receiving ACK2s and ACK3s. Labelers should be assured that all submissions in the queue are getting processed and ACKs will be sent out, but if the volume of submissions becomes too large, some lag time may still be experienced. Labelers who use the GUDID web interface to submit DI records are not affected by these delays.

As specified in the GUDID Guidance document, we will consider labelers to have complied with the requirements of 21 CFR 830.330 on the date that the DI record is saved in GUDID in the published state.  In other words, the Publish Date indicated in the DI record is used to determine compliance. Delays in submission processing and delivery of ACKs will not affect the DI record Publish Date.

As a reminder, the GUDID information becomes available to the public through AccessGUDID after the grace period, which is currently set at 30 days after the date the DI record is published.

We remain committed to providing the medical device industry, health care systems, clinicians and patients the assistance and information needed to implement and use UDI successfully. For additional information, please see www.fda.gov/udi or contact us at the FDA UDI Help Desk.

Sincerely,

FDA UDI Team

Center for Devices and Radiological Health

Food and Drug Administration