Top FDA GUDID HL7 SPL Submission Tools & Third-Party Submitters

FDA gives labelers two ways to submit UDI data to GUDID: manual entry in the GUDID web app or HL7 SPL XML file submission via the FDA Electronic Submissions Gateway (ESG). This directory compares software and third-party submitters that help you operationalize the HL7 SPL path—or manage the data end-to-end.

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Compare FDA GUDID Submission Tools Providers

For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.

Reed Tech — SingleSource for Medical Devices

Reed Tech provides expert UDI data management and submission services for medical device manufacturers, ensuring compliance with global health authorities. They offer SaaS solutions and outsourced services for product data lifecycle management.

LexisNexis Reed Tech, operating as SingleSource for Medical Devices, specializes in managing medical device Unique Device Identification (UDI) product data for global health authorities. They serve a wide range of clients, from small to mid-size producers to the largest global leaders in the pharmaceutical and medical device industries. Their core business revolves around ensuring compliance with UDI regulations. Reed Tech offers a compliant SaaS environment for managing UDI data throughout the product lifecycle, with scalability for increasing volumes and global health authority requirements. They have active UDI channels for the US FDA, China NMPA, South Korea MFDS, and are preparing for EU EUDAMED and Australia UDID. Services include the SingleSource™ UDI Submission SaaS Solution, which allows medical device labelers to manage UDI record submission and product data lifecycle management directly. For organizations with limited resources, the SingleSource™ UDI Premium SaaS Solution provides guided support for UDI submissions. Additionally, they offer GDSN syndication of product data to meet requirements from governmental authorities and buyers. Reed Tech also provides regulatory consulting and outsourced services such as Structured Product Labeling (SPL) for US FDA product listings, eCTD, US Agent services, and other drug listing & establishment registration services. Their expertise in medical device regulatory requirements and UDI data management aims to improve outcomes for healthcare providers and patients.
Website: reedtech.com
HQ: Horsham, US
Languages: English
Pricing model: Monthly subscription
Route: Managed Service
Capabilities: SPL Generation, GDSN
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Innovit — GUDID Connector / UDI Connector

Innovit provides GDSN and UDI compliance solutions, specializing in data syndication and master data management for the healthcare and supply chain industries. They help businesses navigate complex regulatory requirements globally.

Innovit offers specialized solutions for Global Data Synchronization Network (GDSN) and Unique Device Identification (UDI) compliance, crucial for businesses operating in regulated sectors like healthcare. Their GDSN.cloud platform enables suppliers to efficiently manage and publish product master data in GDSN-compliant formats, ensuring accuracy and consistency for trading partners such as GPOs, distributors, and hospitals. For UDI compliance, Innovit provides a comprehensive reference center and tools to help companies navigate the complexities of global UDI regulations and timelines. They assist in achieving compliance with mandates like AusUDID in Australia and EUDAMED in Europe, offering solutions for data gathering, validation, and submission. Their expertise extends to multi-domain Master Data Management (MDM) and Product Information Management (PIM), helping organizations centralize and master fragmented data across various domains. Innovit's solutions are designed to enhance data quality, reduce operational costs, and streamline regulatory submissions. They are certified by leading GDSN data pool providers and their systems comply with standards like GAMP 5, ensuring robust and reliable data management for critical business operations and regulatory adherence.
Website: innovit.com.au
HQ: Australia
Languages: English
Pricing model: Monthly subscription
Route: GDSN / Data Pool
Capabilities: Validation Tools, GDSN
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Innovatum — ROBAR (HL7 SPL + upload to GUDID)

Cruxi offers an AI-powered platform for streamlining medical device regulatory submissions, including FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks.

Cruxi provides an AI-powered regulatory platform designed to simplify medical device submissions for FDA and global markets. Their services cover a range of regulatory needs, from FDA 510(k) and De Novo Classification Requests (eSTAR) to Q-Submissions, 513(g) Requests, PMA Supplements, and Humanitarian Device Exemptions (HDE). The platform features AI-driven workflows, automated compliance checks, and expert guidance to ensure efficiency and accuracy throughout the submission process. Cruxi aims to be a comprehensive solution for all regulatory requirements, offering 14 distinct services. They emphasize intelligent automation and expert support to navigate complex regulatory landscapes.
Website: innovatum.com
HQ: US
Languages: English
Route: Direct HL7 SPL
Capabilities: SPL Generation, ESG Submission, Validation Tools
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1WorldSync — FDA/GUDID publishing via partner workflow

Cruxi offers AI-powered regulatory submission services for medical devices, streamlining processes like FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks.

Cruxi provides a comprehensive, AI-powered platform designed to simplify medical device regulatory submissions. Their services cover a wide range of FDA and global market needs, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. Leveraging intelligent automation and expert guidance, Cruxi aims to streamline the entire submission workflow, from device classification to the final package, ensuring automated compliance checks at every step. They offer specialized solutions for traditional 510(k) submissions, which typically have a 90-day FDA review period. For novel, low to moderate-risk devices, Cruxi supports the mandatory eSTAR use starting October 1, 2025. Additionally, their platform facilitates formal device classification determinations and supports 180-day, Real-Time supplements with repeatable templates and checklists, making regulatory processes more efficient and manageable for manufacturers.
HQ: US
Languages: English
Pricing model: Custom pricing
Route: Direct HL7 SPL
Capabilities: SPL Generation, ESG Submission, Validation Tools
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Atrify — GUDID publishing via GDSN

Innovit provides GDSN and UDI compliance solutions, specializing in data syndication and master data management for regulatory requirements in healthcare and other industries.

Innovit offers comprehensive solutions for Global Data Synchronization Network (GDSN) and Unique Device Identification (UDI) compliance, crucial for directory listings and regulatory submissions. Their GDSN.cloud platform facilitates the efficient publication of product master data to trading partners, ensuring data quality and adherence to GS1 standards. This is particularly beneficial for suppliers in the healthcare sector needing to synchronize data with GPOs, distributors, and hospitals. For UDI compliance, Innovit provides resources and tools to navigate complex global regulations, including Australia's AusUDID and Europe's EUDAMED. They help companies manage the critical path to UDI key dates and data requirements, mitigating risks associated with non-compliance. Their expertise extends to Master Data Management (MDM) and Product Information Management (PIM), enabling organizations to centralize and govern fragmented data across multiple domains. Innovit's solutions are designed to enhance data accuracy, reduce supply chain costs, and improve operational efficiency. They are certified by leading GDSN data pool providers and their systems are validated to comply with GAMP 5 standards, ensuring robust and reliable regulatory data submissions. Their offerings cater to a range of needs, from managing up to 800 GTINs on GDSN.cloud to comprehensive MDM solutions for large enterprises.
Website: atrify.com
HQ: Sydney, AU
Languages: German
Pricing model: Monthly subscription
Route: GDSN / Data Pool
Capabilities: Validation Tools, GDSN
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Syndigo — Global UDI / content hub positioning

Syndigo is a global UDI/content hub provider, specializing in data and knowledge management solutions. They empower organizations to leverage AI for enhanced decision-making and operational efficiency.

Syndigo offers a global UDI/content hub, positioning itself at the forefront of knowledge management and data integration. The company focuses on merging data and knowledge into unified architectures, enabling organizations to create contextually rich data environments that are actionable for autonomous and semi-autonomous agents. This approach is crucial in the current landscape where AI and machine learning are transforming how businesses operate. Their solutions are designed to enhance productivity, reduce errors, and improve decision-making by providing faster, more accurate access to data and information. Syndigo's expertise extends to implementing foundational technologies for AI projects, ensuring better success rates by focusing on elements like taxonomy and auto-tagging. They emphasize the importance of verified, reliable knowledge, enabling agentic AI that can govern, heal, and surface information to drive measurable outcomes. Syndigo is recognized for its role in the evolving field of Knowledge Management (KM), particularly in adapting to the influence of generative AI. They provide pioneering solutions that address long-standing challenges in organizing and accessing organizational knowledge, fundamentally changing how enterprises conceptualize knowledge as a strategic asset. Their commitment to innovation and agility ensures they remain a key player in empowering intelligent knowledge management for businesses worldwide.
Website: syndigo.com
HQ: Chicago, USA
Languages: English, French, German
Route: Direct HL7 SPL
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Salsify — GUDID publishing capability

Salsify offers a Product Experience Management (PXM) platform that helps businesses centralize, connect, and automate product content for digital commerce. It leverages AI to enhance product data syndication and improve market speed.

Salsify provides a comprehensive Product Experience Management (PXM) platform designed to empower businesses in leading the digital shelf. Their solutions focus on efficiently sourcing supplier product content at scale, transforming digital commerce strategies with AI-powered capabilities. The platform enables companies to centralize all product content, regardless of its origin, and connect it across the digital shelf to deliver engaging product experiences. Salsify is particularly noted for its GDSN (Global Data Synchronization Network) capabilities, offering a GS1-certified and interoperable solution that centralizes and syndicates content from a unified platform, accelerated by AI. This helps businesses connect with trading partners and share product content effectively to win on the digital shelf. Key features highlighted include AI-driven solutions for modern commerce, customer support resources like a Customer Hub and Knowledge Base, and specific functionalities for brands (Centralize, Connect, Automate) and retailers (Onboard, Validate, Automate). Salsify emphasizes time-saving benefits and market differentiation through its intelligent platform, making complex features like formulas more accessible via natural language.
Website: salsify.com
HQ: USA
Languages: English
Pricing model: Custom pricing
Route: GDSN / Data Pool
Capabilities: GDSN
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Freyr Solutions — Managed UDI/GUDID service

Freyr Solutions is a global regulatory solutions and services company specializing in UDI/GUDID services for FDA compliance. They offer end-to-end regulatory support for medical devices, drug development, and more.

Freyr Solutions is a global regulatory solutions and services provider with over 15 years of expertise. They offer comprehensive support for regulatory compliance across various industries, including pharmaceuticals and medical devices. Their services encompass UDI and GUDID solutions for FDA compliance, drug development, regulatory strategy, dossier authoring, post-approval lifecycle management, and country-specific regulatory services. Leveraging their AI-first regulatory platform, 'freya fusion,' Freyr assists businesses in navigating complex compliance needs throughout the entire regulatory lifecycle. They have a strong presence in over 150 countries and expertise in more than 16 therapeutic areas. Freyr is recognized for its ability to transform regulatory intelligence processes and deliver real regulatory wins, turning compliance into success for their clients. With strategically located offices worldwide, including in the United States, Freyr provides specialized UDI and GUDID services to help medical device manufacturers meet US FDA requirements. They offer expert guidance on UDI implementation, GUDID database submissions, and ensure accurate data management for device traceability and patient safety.
HQ: Princeton, USA
Languages: English
Pricing model: Custom pricing
Route: Managed Service
Capabilities: ESG Submission
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GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

HQ: Boston, US
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Route: Direct HL7 SPL
Capabilities: SPL Generation, ESG Submission, Validation Tools, GDSN
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MedReg International Pro

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.

HQ: London, UK
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Route: Direct HL7 SPL
Capabilities: SPL Generation, ESG Submission, Validation Tools, GDSN
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Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

HQ: San Francisco, US
Jurisdictions: EU, UK, US
Countries: DE, FR, GB, US
Languages: English, French, German, Spanish
Response SLA: 24 hours
Onboarding time: 7–30 days
Pricing model: Custom pricing
Route: Direct HL7 SPL
Capabilities: SPL Generation, ESG Submission, Validation Tools, GDSN
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Comprehensive Buyer's Guide

1. Who Needs GUDID Submission Tools?

Medical device manufacturers placing devices on the U.S. market must submit UDI data to FDA's GUDID (Global Unique Device Identification Database)[1].

This requirement applies to:

  • Medical device manufacturers with higher-volume or bulk submissions needing automated workflows
  • Organizations wanting to integrate GUDID submission with existing UDI data management systems
  • Companies needing HL7 SPL generation and ESG submission support
  • Manufacturers requiring validation tools for UDI data

Submission paths: FDA provides two ways to submit: (1) Manual entry via the GUDID web app (suitable for low-volume), and (2) HL7 SPL XML file submission via ESG (suitable for bulk/higher-volume). The platforms in this directory help operationalize the HL7 SPL path.

References

  1. FDA Submit Data to GUDID (FDA) — 2025-12

2. Which Submission Path Fits You?

GUDID Web App

Best for: Low-volume, manual submissions. Suitable for occasional entries or small device portfolios. No technical setup required, but not scalable for bulk operations.

HL7 SPL via ESG

Best for: Bulk submissions, higher volume, automated workflows. More technical but scalable. Requires HL7 SPL XML generation and ESG registration. The platforms in this directory help operationalize this path.

Why platforms exist: Building HL7 SPL files manually is error-prone and time-consuming. Third-party platforms generate valid SPL, validate UDI data, handle ESG submissions, and provide lifecycle management—reducing compliance risk and operational overhead.

3. What Services Are Typically Included?

GUDID submission tools typically offer:

  • HL7 SPL Generation: Generate valid HL7 SPL XML files from UDI data
  • ESG Submission: Handle submission to FDA's Electronic Submissions Gateway
  • Validation Tools: Validate UDI data before submission
  • GDSN Integration: Some platforms support GDSN (Global Data Synchronization Network) routes to GUDID
  • Lifecycle Management: Manage device data, updates, and submissions over time
  • Managed Services: Some providers offer fully managed submission services

4. What Affects Pricing?

GUDID submission tool pricing varies based on:

  • Submission route: Direct HL7 SPL/ESG, GDSN/Data Pool, or Managed Services
  • Number of devices: Per device or per submission pricing
  • Service scope: Software-only vs. managed services (provider handles submissions)
  • Features: Basic SPL generation vs. advanced features (validation, GDSN, lifecycle management)
  • Volume: Number of submissions, updates, devices

Pricing models: Most providers use per-device, per-submission, or monthly subscription models. Enterprise solutions are typically quote-based.

5. How to Choose a Provider

Key factors to consider:

  • Submission route: Which route fits your needs (Direct SPL/ESG, GDSN, or Managed Services)?
  • SPL generation: Do they generate HL7 SPL files, or do you need to provide pre-generated SPL?
  • ESG handling: Do they handle ESG submission, or do you need to register with ESG separately?
  • Validation: What validation tools do they provide for UDI data?
  • GDSN: Do you need GDSN integration?
  • Support: What level of support is included?

Frequently Asked Questions

Q1: 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. The HL7 SPL route is more technical but scalable for manufacturers with many devices.

References

  1. FDA Submit Data to GUDID (FDA)

Q2: What is a third-party submitter?

A third-party submitter is an authorized vendor or contractor that submits GUDID data on behalf of the labeler. The labeler retains full compliance responsibility, but the submitter handles the technical submission process (HL7 SPL generation, ESG upload, etc.).

References

  1. FDA Guidance: Third-Party Submitter (PDF) (FDA)

Q3: 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. The web app is suitable for occasional manual entries but becomes impractical at scale.

Q4: Do I still own compliance if a vendor submits for me?

Yes. The labeler (manufacturer) retains full compliance responsibility even when using a third-party submitter. The submitter acts as an authorized agent, but the labeler is ultimately responsible for data accuracy and regulatory compliance.

Q5: What's ESG?

ESG (Electronic Submissions Gateway) is FDA's secure portal for receiving electronic submissions, including HL7 SPL files for GUDID. Labelers or their authorized third-party submitters must register with ESG and use it to upload HL7 SPL XML files.

References

  1. FDA Submit Data to GUDID (FDA)

Related Regulatory Services

EU Authorized Representative (EU AR) UK Responsible Person (UK RP) Swiss Authorized Representative (CH-REP) Person Responsible for Regulatory Compliance (PRRC) EU+UK Cosmetics Compliance DSA Article 13 Representative

Provider Comparison Table

Provider CoverageKey Features Languages Response SLA
Reed Tech — SingleSource for Medical Devices Request quote English Request quote
Innovit — GUDID Connector / UDI Connector Request quote English Request quote
Innovatum — ROBAR (HL7 SPL + upload to GUDID) Request quote English Request quote
1WorldSync — FDA/GUDID publishing via partner workflow Request quote English Request quote
Atrify — GUDID publishing via GDSN Request quote German Request quote
Syndigo — Global UDI / content hub positioning Request quote English, French Request quote
Salsify — GUDID publishing capability Request quote English Request quote
Freyr Solutions — Managed UDI/GUDID service Request quote English Request quote
GlobalCompliance Solutions Pro EU, UK Request quote English, French 24h
MedReg International Pro EU, UK Request quote English, French 24h

Sources & Official Guidance

Official sources vary by directory. See the applicable regulation and competent authority guidance for this role.

Last Updated: 2026-02-04
Reviewed by: Cruxi Regulatory Affairs Team
Cruxi - Regulatory Compliance Services