For medical devices, SPL (Structured Product Labeling) applies specifically to submitting UDI data to FDA’s Global Unique Device Identification Database (GUDID). General device establishment registration and listing go through FURLS’s Device Registration and Listing Module directly, not SPL, and 510(k)/PMA labeling is submitted as part of your premarket submission, not as a standalone SPL file. We handle all three, correctly routed to the right system.
GUDID & UDI Submission (SPL)
UDI data can be submitted to GUDID two ways: manual entry through FDA’s web interface, or HL7 SPL files via the FDA Electronic Submissions Gateway (ESG) for bulk or high-volume submissions. We prepare and submit your UDI records in HL7 SPL format so your device identifiers are accurate and submitted efficiently, especially useful once you’re managing more than a handful of devices.
- HL7 SPL file preparation for GUDID
- Electronic Submissions Gateway (ESG) account setup and submission
- Device Identifier (DI) record management
- UDI data element accuracy review
Device Establishment Registration & Listing
Establishment registration and device listing are handled directly in FURLS’s Device Registration and Listing Module (DRLM), through web entry or a formatted spreadsheet upload, separate from SPL. We manage this filing on your behalf, including the annual October 1 to December 31 renewal window.
- FURLS/DRLM establishment registration
- Device listing entry and maintenanceAnnual renewal filing
- Annual renewal filing
- Product code and GMDN coordination
510(k) & PMA Labeling Submission Support
Device labeling, instructions for use, and package inserts are submitted as part of your 510(k) or PMA submission package through FDA’s standard device submission process, not in SPL format. We help prepare and organize labeling content so it’s ready for your premarket submission.
- Instructions for use (IFU) preparation support
- Package insert content review
- 510(k) labeling submission coordination
- PMA labeling submission coordination
Ongoing Updates
When your device information changes, different updates go to different places. Listing changes go through FURLS/DRLM, UDI/GUDID record changes go through SPL or the GUDID web interface, and labeling changes route through your next submission or amendment. We track which is which and keep all three current.
- FURLS/DRLM listing amendments
- GUDID/UDI record updates (SPL or web entry)
- Labeling change tracking
- Version control across all three systems
Need Help Identifying the Right System for Your Device Data?
GUDID, FURLS, and your 510(k)/PMA submission all have different formats and deadlines. We manage all three so nothing falls through the cracks.
SPL & Device Data Submission FAQs
No. SPL is used for submitting UDI data to GUDID, not for general device establishment registration or listing. Device listing is handled directly in FURLS’s Device Registration and Listing Module.
SPL (Structured Product Labeling) is an HL7 data standard. For devices, its main use is submitting UDI records to FDA’s Global Unique Device Identification Database (GUDID), typically via the Electronic Submissions Gateway for bulk submissions. Manual entry through GUDID’s web interface is the alternative if you’re not submitting in bulk.
No. Device labeling, instructions for use, and package inserts are submitted as part of your premarket submission package, not as separate SPL files.
Device listing identifies your establishment and the devices you make, filed through FURLS. UDI/GUDID submission provides the specific identifier data for each device, filed separately through GUDID. Most manufacturers need to keep both current.
Whenever device information changes, new device versions, model changes, or other identifier-relevant updates, your GUDID record needs to reflect it. This is separate from your annual FURLS listing renewal.