The HL7 SPL Submission option enables companies to electronically submit device information one DI record at a time as an HL7 SPL xml file.
HL7 is a not for profit, American National Standards Institute (ANSI) accredited standards development organization, whose mission is to provide messaging standards for healthcare interoperability, exchange, management, and integration of data that supports clinical patient care and the management, delivery, and evaluation of healthcare services.
Structured Product Labeling (SPL) is a HL7 standard for the exchange of product information using extensible markup language (XML). For GUDID, the FDA will use the HL7 SPL Release 5, Draft Standard for Trial Use (DSTU), to receive device identification information.
Companies that plan to use the HL7 SPL submission option will need to do the following:
- Establish a GUDID account.
- Use the FDA Electronic Submissions Gateway to submit HL7 SPL files.
- Complete ESG account establishment and testing process.
- Once GUDID and ESG accounts are established, companies will be required to complete GUDID testing prior to production submissions. Detailed information on testing requirements/process is provided in the HL7 SPL Implementation Files – April 14, 2016. The files have been updated to include GUDID v1.2.3 HL7 SPL Production release information.