Dear UDI and GUDID Email Subscribers,
The GUDID HL7 SPL Implementation Files have been updated and are presently available on our website.
The updates were made for GUDID Release 1.1 and include the following --
- Changes to the folder naming structure for HL7 SPL submissions.
- Ability to submit FDA Preferred Term (PT) Codes – as stipulated in the Final UDI Rule, FDA has developed a new GUDID module, Find FDA PT Codes, to enable users to select a FDA PT Code for GUDID submissions until a GMDN PT code can be obtained from the GMDN Agency. FDA PT Codes are a unique 4-letter code assigned to each GMDN PT Name, in place of the GMDN PT Code. The Find FDA PT Code module is enabled in GUDID Release 1.1 and can be accessed via the GUDID Web Interface by Coordinator and Labeler Data Entry (LDE) Users of GUDID. These FDA PT codes can also be submitted in HL7 SPL xml submissions.
For all questions on UDI and GUDID, please contact the FDA UDI Help Desk.
Sincerely,
FDA UDI Team
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