The U.S. Food and Drug Administration (FDA) hosted two webinars on January 14, 2015. Yesterday, Registrar Corp published a summary of the first webinar, “UDI 101.” Today we’re summarizing FDA’s second webinar, “Getting Ready for GUDID.”
“Getting Ready for GUDID” was presented by Indira R. Konduri, FDA’s GUDID Program Manager. She offered a list of steps for labelers to take before submitting information to the GUDID. Konduri noted that the PI portion of a device’s UDI is not stored in the GUDID. Labelers only indicate the type of information used in the PI (manufacturing date, batch number, etc.). The GUDID contains only the DI portion, so information submitted to the database about a device is called a DI record.
1. Her first step was for labelers to familiarize themselves with the UDI and GUDID regulations. She directed labelers to FDA’s UDI Resources webpage. The regulations are extensive, and the resources webpage contains many documents, so if you have any questions, Registrar Corp is available 24 hours a day to help labelers navigate the UDI regulations.
2. Konduri’s second step was for the labeler to select an agency to issue its UDI. There are currently three accredited issuing agencies:
- Health Industry Business Communications Council (HIBCC)
3. The third step was to choose a submission option. DI records can either be submitted through the web interface or through the Health Level 7 (HL7) option. Labelers can only submit one DI record at a time through the web interface. The web interface allows users to create draft records, which are visible only to the user, and does not require testing before submitting records.
HL7 allows users to submit multiple DI records at once using xml files. With HL7 there is no option to create draft records and users must complete GUDID testing using a test account before submitting the final production DI records.
4. After choosing a submission option, Konduri advised labelers to gather device identification data. Labelers are required to identify a Global Medical Device Nomenclature (GMDN) preferred term for each device they submit to the GUDID. Konduri suggested that labelers identify these terms right away because it can take a substantial amount of time. Labelers are also required to identify an FDA listing number for each device.
5. The fifth step was to understand the GUDID account structure. A device establishment’s regulatory contact should have only one GUDID account. However, other users from the establishment may have more than one. You can view a diagram of the account structure on page 8 of this guidance.
6. Konduri’s sixth step was to identify or obtain a Data Universal Numbering System (DUNS) number. DUNS numbers are used to identify labeler organizations in GUDID. Labelers do not supply their name and address to the GUDID. This information is pulled from the DUNS database.
7. After taking the prior steps to prepare, step seven is to create a GUDID account. If a labeler decides to use the web interface submission method, Konduri recommends that he get familiar with the system after creating his account by creating draft DI records. These drafts are not visible to FDA. Final versions of DI records may be submitted through the web interface for “future” publication dates. Labelers have a 7-day grace period that begins after the publication date to make any necessary changes.
For labelers who decide to use the HL7 submission method, Konduri said they must first create an FDA Electronic Submissions Gateway (ESG) account and complete ESG testing. After ESG testing is completed, the labeler should request a GUDID Test Account and complete HL7 testing. Finally, once the labeler has completed both types of testing, he may obtain a GUDID account for production submissions. There is no grace period for HL7 submissions.
8. Konduri’s final step for labelers was to subscribe to GUDID System Status Updates. Subscribers will receive information about scheduled downtimes for the database through e-mail alerts.
According to Konduri, implantable, life-supporting and life-sustaining device labelers will be able to request GUDID accounts beginning Monday, January 26, 2015. FDA plans to accept GUDID account requests from Class II labelers later in 2015. Keep in mind that a labeler cannot create a GUDID account until he has an FDA-cleared device to submit to the database.
FDA is working with the National Library of Medicine to provide the GUDID to the public to search and download. The agency’s goal is for the GUDID to be public in Spring 2015.
A labeler can designate a third-party submitter to submit information to the GUDID on his behalf. Registrar Corp is an FDA compliance firm that helps medical device establishments comply with FDA regulations. Registrar Corp can assist an establishment in determining the UDI requirements for a specific device and in submitting information to the GUDID. If you have any questions regarding UDI or GUDID regulations or would like assistance, contact Registrar Corp at +1-757-224-0177 or through the 24-hour online Live Help service.