Reed Tech — SingleSource for Medical Devices vs Innovatum — ROBAR (HL7 SPL + upload to GUDID)
GUDID HL7 SPL Submission Tools Comparison (2025)
Updated: December 2025Choose Reed Tech — SingleSource for Medical Devices if...
SPL submissions + lifecycle management for medical device manufacturers Generates HL7 SPL. Validation tools available.
Choose Innovatum — ROBAR (HL7 SPL + upload to GUDID) if...
HL7 SPL generation and GUDID submission options Generates HL7 SPL.
Side-by-Side Comparison
| Feature | Reed Tech — SingleSource for Medical Devices | Innovatum — ROBAR (HL7 SPL + upload to GUDID) |
|---|---|---|
| Route | Direct HL7 SPL / ESG Submitter | Direct HL7 SPL / ESG Submitter |
| Best for | SPL submissions + lifecycle management for medical device manufacturers | HL7 SPL generation and GUDID submission options |
| Generates HL7 SPL | ✓ | ✓ |
| 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.