What is GUDID? FDA Medical Device Database Guide (2026)
If you manufacture medical devices and sell them in the United States, your devices live in GUDID. The Global Unique Device Identification Database is where the FDA keeps a record of every device cleared for the US market — what it is, who makes it, how it is packaged, how it should be used.
GUDID has been operational since 2013, but for years many manufacturers treated it as an administrative formality. That changed in February 2026, when the FDA tightened its inspection program around UDI data quality and started enforcing GUDID compliance through audits. The database is now a regulatory checkpoint, not a paperwork exercise.
This guide explains what GUDID is, who must submit data, how submission works, and how GUDID relates to the other regulatory databases your team will eventually face — starting with EUDAMED.
1. What GUDID stands for
GUDID is short for Global Unique Device Identification Database. It is a database administered by the U.S. Food and Drug Administration (FDA) and serves as a reference catalog for devices that carry a Unique Device Identifier (UDI).
GUDID sits inside the broader UDI framework established by the FDA’s UDI final rule published on September 24, 2013 (78 FR 58786) and codified in the UDI regulations, including 21 CFR Part 830.
UDI requirements apply broadly, but the rule includes exceptions and alternatives. Where they apply, device labelers must both (1) place a UDI on labels and packages (and in some cases directly on the device), and (2) submit the required device identifier information to GUDID.
One distinction matters from the start: the public-facing access point is AccessGUDID, which the FDA created in collaboration with the U.S. National Library of Medicine (NLM) to make GUDID device identification information available to everyone.
2. AccessGUDID vs. the GUDID Web Interface
AccessGUDID is the public portal for GUDID device identification data. It is open to anyone — patients, hospitals, researchers, industry — and does not require an account. It supports search and bulk data download.
The GUDID Web Interface is the secure FDA application device labelers and authorized users rely on to create and manage GUDID device identifier (DI) records. The FDA’s GUDID guidance describes it as the module where accounts are created and DI records are submitted and managed.
If you are looking for “GUDID login”, you are typically looking for the FDA login entry point to the GUDID system.
3. What data goes into GUDID
GUDID is built around the UDI, which has two parts:
- The Device Identifier (DI): the mandatory, fixed portion of the UDI that identifies the labeler and the specific version or model of a device.
- The Production Identifier(s) (PI): the conditional, variable portion of a UDI that can include lot or batch number, serial number, expiration date, manufacturing date, and — for certain HCT/Ps regulated as devices — a distinct identification code.
GUDID contains only the DI portion of the UDI as the primary key for obtaining device information. PIs are not submitted to or stored in GUDID; instead, GUDID includes PI flags indicating which PI attributes appear on the device label (unless excepted).
The data content of a DI record is defined by FDA requirements: GUDID includes the data elements required by 21 CFR 830.310, plus administrative elements used to maintain the system and support integration with FDA systems.
UDIs are created and maintained by device labelers using standards managed by FDA-accredited issuing agencies. As of the GUDID guidance publication date, the FDA has accredited three: GS1, HIBCC, and ICCBBA.
4. Who must submit data to GUDID
Under the UDI rule, device labelers must submit DI and required device attribute information to GUDID when their devices are subject to UDI requirements, unless an exception or alternative applies.
The FDA implemented these requirements through a phased approach based on device class and risk. The official compliance dates include these milestones:
- September 24, 2014: Class III devices (and certain PHS Act devices) must bear a UDI; data must be submitted to GUDID.
- September 24, 2015: implantable, life-supporting, and life-sustaining devices.
- September 24, 2016: Class II devices.
- September 24, 2018: Class I and unclassified devices must bear a UDI on labels and packages.
For Class I and unclassified devices, the FDA later published a compliance policy stating it did not intend to enforce GUDID submission requirements (other than for implantable/life-supporting/life-sustaining devices) before December 8, 2022.
5. How to submit data to GUDID
The FDA provides two submission options for GUDID data.
Option 1 — GUDID Web Application (manual entry)
The GUDID web application supports manual entry of DI records one at a time. The FDA positions it as best suited for small volumes of records.
Option 2 — HL7 SPL via the FDA Electronic Submissions Gateway (ESG)
For higher volumes, the FDA accepts DI records in HL7 SPL (Structured Product Labeling) XML format, transmitted through the FDA Electronic Submissions Gateway (ESG). FDA regulations specify that required GUDID information must be submitted electronically in a processable format, unless a waiver applies.
Where machine-to-machine platforms fit
Many companies operationalize submissions using internal tooling or third-party solutions, but the submission still occurs through one of the FDA’s accepted mechanisms (the web application or HL7 SPL via the ESG). The FDA’s GUDID guidance explicitly recognizes the use of third-party submitters (vendors or contractors) on behalf of the labeler — but the labeler remains ultimately responsible for the information submitted to GUDID.
6. How to access GUDID data
Public access is available through AccessGUDID, created in collaboration with the NLM, which lets users search device identification information and download data. Published GUDID DI data is also available via AccessGUDID and OpenFDA, with certain exceptions for non-public attributes.
Manufacturer access to create and manage DI records occurs through the FDA’s secure GUDID environment (the GUDID Web Interface) and requires a GUDID account. A GUDID account is not needed for public search and retrieval of published information.
On the account side, the FDA uses DUNS numbers to identify labeler organizations and ties each GUDID account to an organization DUNS number. The guidance describes roles such as Regulatory Contact, Coordinator, and Labeler Data Entry (LDE) users, and the information required when requesting an account.
7. GUDID and the FDA Compliance Program 7382.850
The FDA’s Compliance Program Manual CP 7382.850 (“Inspection of Medical Device Manufacturers”) has an implementation date of February 2, 2026 and explicitly includes UDI among the “Other Applicable FDA Requirements (OAFRs)” evaluated during inspections (with stated exceptions such as PMA preapproval inspections).
In its UDI section, CP 7382.850 restates that the UDI final rule requires device labelers to (1) include a UDI on device labels and packages (and in some cases directly on the device) and (2) submit device information to GUDID.
The program then gives concrete inspectional instructions. Investigators are directed to confirm that data elements in AccessGUDID — DI information, device characteristics, alternative/additional identifiers, and customer contact sections — match the device labeling and the UDI on the device, and to verify that discontinued devices have updated “Commercial Distribution Status” and “Commercial Distribution End Date” fields.
It also lists Device Identifier records in GUDID among the sources investigators review to identify product risks ahead of an inspection.
For a step-by-step view of how investigators apply this program during an inspection, see our guide to the FDA Compliance Program 7382.850.
8. GUDID vs. EUDAMED — same operational challenge, different frameworks
If you sell devices in both the U.S. and Europe, you will work with both GUDID and EUDAMED. They were designed by different regulators and operate under different legal and data frameworks. (This section is a practical, cross-regulatory perspective and is not presented as FDA guidance.)
The strategic reality for global manufacturers is that the hardest part is not the transmission format — it is establishing a clean, governed device master dataset that can be mapped to each jurisdiction’s requirements. Once that dataset is robust, multi-jurisdiction submissions become a matter of controlled mapping and disciplined updates.
We compare the two systems in depth — data scope, submission logic, and where they overlap — in our guide on the differences between EUDAMED and GUDID.
