Medical Devices



Join the SPL Medical Device Subteam

If you are interested in participating on the Medical Device Subteam, contact the group lead.

The SPL Technical Team is a part of this working group and also a participant in the HL7 Structured Product Labeling standard development project. More information can be found on the Technical Team page in this wiki.

Resources and Links

UDI Presentation (provided by FDA):



Guidance for Industry: Global Unique Device Identification Database (GUDID):

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM400261.pdf

Device attribute information that will populate the GUDID: “GUDID Data Elements Reference Table


For all questions on UDI and GUDID, please contact the FDA UDI Help Desk.
Device Classification Search


Submission of electronic files (not SPL) for Devices via eSubmitter.



Meeting Minutes:
May 21, 2009 minutes