Reed Tech subject matter experts recently attended a number of industry trade events where they received additional information and clarification from FDA on GUDID submissions. As you may be aware, Class III medical device labelers must submit the required UDI data attributes to FDA by September 24, 2014. Regardless of submission option chosen, FDA requires the setup of a production GUDID Account (see Step 1.B. in the Steps to Comply graphic for more information). Currently, FDA is accepting GUDID Account requests from Class III manufacturers only. However, Class III manufacturers may also choose to submit any Class II and Class I data they might have in their GUDID submissions at this time.
One of the first steps in submitting data to the GUDID is to complete the setup of a GUDID Account. Labelers requesting a GUDID Account will receive the FDA Global Unique Device Identification Database (GUDID) New Account Request document. This document requires labelers to submit several items in reference to GUDID submissions. One of those required fields is GUDID Submission Option, with the choices: Web Interface ONLY, HL7 SPL files via FDA ESG ONLY, or Web Interface and HL7 SPL. We’ve recently learned from the FDA that they prefer labelers remain consistent in the submission method chosen throughout the submission of all classes of devices, grace period editing, and maintenance of the data.
Additionally, labelers utilizing the HL7 SPL submission option must complete ESG account establishment and testing procedures, which requires a series of test submissions. These test submissions ensure that, as a labeler transitions to production submissions, there will be no problems caused by improper formatting, incorrect values, or validation failures in the submission. These test submissions must be scheduled and received live by FDA personnel through the FDA UDI Help Desk.
Reed Tech also learned that as of May 19, only 79 GUDID production accounts had been activated with the GUDID containing a total of 201 submissions. With over 700 Class III manufacturers, this signifies that only 11% of manufacturers have taken the first steps toward meeting the upcoming September 24 deadline.
With this in mind, it is recommended that Class III manufacturers begin the process of establishing a GUDID Account as soon as possible. For more information on how Reed Tech may assist you in meeting the GUDID submission requirement, please feel free to contact me directly.