What is GUDID and which devices require it?

The Global Unique Device Identification Database (GUDID) is FDA's repository for device identifier information. Class III devices (and higher risk Class II/I) are required to submit UDI-DI data to GUDID.

What submission routes are available for GUDID?

You can submit via (1) direct web entry in the GUDID portal, (2) HL7 SPL electronic file submission, or (3) GDSN (Global Data Synchronization Network). File-based submissions require HL7 SPL expertise.

How often does GUDID data need to be updated?

GUDID data must be updated whenever device labelling changes affect any of the required data elements (e.g., device name, DI, size, sterility, expiry indication, MRI safety).

Book a US FDA GUDID Device Identifier (DI) Submission

Book FDA GUDID device identifier submission support online. Compare vetted UDI/GUDID specialists for HL7 SPL submissions to the Global UDI Database. Instant pricing.

✓ 3 active providers available right now · USD 387 – 480

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What you can compare here

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Coverage & scope: Markets served, what is included, and what is explicitly excluded.
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Add-ons: Optional extras you can book next (shown as add-on chips).
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Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 420	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 480	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 387	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

diCount (Required)
min 1
deviceClass (Required)
I|II|III
complexity (Required)
simple|normal|complex
turnaround (Required)
standard|rush
desiredOutputs (Required)
min 1
buyerNotes (Optional)

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Market

United States

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Database

FDA GUDID

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Turnaround

2–7 business days

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Pricing

Per device identifier

Want to read provider profiles and reviews first? Compare all GUDID submission specialists →

How it works

1

Tell us about your device identifiers

Enter the number of DIs, your device class, and preferred submission route (HL7 SPL, GDSN, or web direct).
2

Compare GUDID submission specialists

View per-DI fees and turnaround from providers experienced with FDA CDRH Access portal and GUDID submissions.
3

Receive GUDID confirmation

Your specialist submits the DI data and provides GUDID publication confirmation for your UDI compliance records.

What is GUDID and why is UDI submission required?

The Global Unique Device Identification Database (GUDID) is FDA's official database of medical device identification information, accessible publicly at accessgudid.nlm.nih.gov. It is part of FDA's Unique Device Identification (UDI) system established under 21 CFR Part 830 and the Unique Device Identification System: UDI 2013 final rule. UDI requires that labelers (generally manufacturers or specification developers) submit Device Identifier (DI) data to GUDID before the device is placed in commercial distribution in the US. GUDID data is used by hospitals for device tracking, procurement, and adverse event reporting — accurate entries directly support patient safety and supply chain traceability.

UDI-DI vs. UDI-PI: what each covers

The Unique Device Identifier has two components. The UDI-DI (Device Identifier) is the static part — it identifies the specific version or model of a device and its labeling. The UDI-DI is what gets submitted to GUDID. The UDI-PI (Production Identifier) is the dynamic part — it identifies the specific unit of production using lot/batch number, serial number, manufacture date, and/or expiry date. Only the UDI-DI is submitted to GUDID; the UDI-PI appears on the physical device label and packaging. When a labelling change is significant enough to require a new DI, the old GUDID entry must be updated to reflect "discontinued" status and a new DI record created.

GUDID submission methods and timelines

There are three routes to submit to GUDID: (1) direct web entry via the FDA CDRH Access portal — practical for small device portfolios with infrequent updates; (2) HL7 SPL (Structured Product Labeling) electronic file submission — used by high-volume labelers submitting dozens or hundreds of DIs; and (3) GDSN (Global Data Synchronization Network) — for manufacturers already using GS1 data pools for supply chain data exchange. HL7 SPL requires technical expertise in the SPL format. GUDID entries must be submitted prior to commercial distribution — retroactive submissions are non-compliant. FDA compliance dates vary by device class, so confirm the applicable deadline for your device.

What data must be included in a GUDID record?

A GUDID DI record must include: the labeler DUNS number; Device Identifier (barcode/RFID value); Company name and device name; Device description and version or model number; whether the device has a single use, sterile, implantable, or MRI safety status; storage and handling conditions; size data (if applicable); and required production identifiers (lot, serial, manufacture date, expiry). Optional but recommended fields include device class, regulation number, and premarket submission reference. Incomplete or inaccurate GUDID records can lead to procurement matching failures in hospital EHR systems and potential FDA compliance flags during inspections.

Frequently asked questions

What is GUDID and which devices require it?: The Global Unique Device Identification Database (GUDID) is FDA's repository for device identifier information. Class III devices (and higher risk Class II/I) are required to submit UDI-DI data to GUDID.
What submission routes are available for GUDID?: You can submit via (1) direct web entry in the GUDID portal, (2) HL7 SPL electronic file submission, or (3) GDSN (Global Data Synchronization Network). File-based submissions require HL7 SPL expertise.
How often does GUDID data need to be updated?: GUDID data must be updated whenever device labelling changes affect any of the required data elements (e.g., device name, DI, size, sterility, expiry indication, MRI safety).

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