1WorldSync — FDA/GUDID publishing via partner workflow vs Atrify — GUDID publishing via GDSN
GUDID HL7 SPL Submission Tools Comparison (2025)
Updated: December 2025Choose 1WorldSync — FDA/GUDID publishing via partner workflow if...
GDSN data pool route to GUDID with quality assurance framework Generates HL7 SPL. Validation tools available.
Choose Atrify — GUDID publishing via GDSN if...
GDSN route to GUDID for medical device manufacturers
Side-by-Side Comparison
| Feature | 1WorldSync — FDA/GUDID publishing via partner workflow | Atrify — GUDID publishing via GDSN |
|---|---|---|
| Route | GDSN / Data Pool route | GDSN / Data Pool route |
| Best for | GDSN data pool route to GUDID with quality assurance framework | GDSN route to GUDID for medical device manufacturers |
| Generates HL7 SPL | ✓ | Not stated publicly |
| Handles ESG submission | Not stated publicly | Not stated publicly |
| Validation / QA tools | ✓ | Not stated publicly |
| Pricing | Quote-based | Quote-based |
Choosing the right route
If you submit high volumes or need automated updates, HL7 SPL via ESG is typically required. Lower‑volume teams may start with the web app and migrate later. If you also need UDI strategy or regulatory support, explore the Cruxi directories hub.
FAQ
What are the two ways to submit data to GUDID?
FDA provides two submission paths: (1) Manual entry via the GUDID web app for low-volume submissions, and (2) HL7 SPL XML file submission via the FDA Electronic Submissions Gateway (ESG) for bulk/higher-volume submissions.
When should I use HL7 SPL instead of the web app?
Use HL7 SPL via ESG for higher-volume or bulk submissions, when you need automated workflows, or when integrating with existing UDI data management systems.