GUDID and AccessGUDID: What the Database Holds and How to Search It

GUDID is the Global Unique Device Identification Database. FDA runs it, and device labelers fill it. Each record describes one version or model of a device and is keyed by its device identifier (DI). AccessGUDID is the public search and download site, run by the National Library of Medicine with FDA. The full release of 2 November 2026 held 5,258,157 DI records.

This page covers what a record contains, who must submit it and when, how to search and download the data, and how FDA checks it on inspections. The label side of the system is in the entry on unique device identification.

What a record holds

A UDI is a device identifier plus production identifiers (lot, serial number, expiry and manufacturing date). GUDID holds the first part only. FDA's GUDID guidance says production identifiers are not submitted to or stored in GUDID. A record carries a flag for each production identifier that says whether the label shows it.

Section 830.310 lists what a labeler submits. The public fields include:

• the labeler's name, the issuing agency, the DI and any previous DI
• brand name and version or model number
• whether the device is sterile, contains natural rubber latex, or has an MRI safety status
• size and unit of measure, and the device count in the package
• the premarket submission number (510(k), De Novo or PMA), or an exempt status
• the GMDN term code

Three items are not public. The FDA listing number and the company's physical address are withheld, as is the regulatory contact the labeler designates under 830.320. FDA's data elements table (updated 17 December 2024) marks each field. A premarket number appears only where it is releasable. The record holds no patient data and no sales or distribution data. It says what a device is, not where units went.

Who submits, and by when

Section 830.300(a) puts the duty on the labeler of each version or model that must bear a UDI. For most devices the labeler is the manufacturer. A third party can enter the data, but FDA's guidance says the labeler stays responsible for it.

Section 830.330 sets the timing:

• The initial record is due no later than the date the label must bear a UDI under 801.20.
• A change to the record is due no later than the date the device is first labeled with the changed information. If the information is not on the label, the change is due within 10 business days.
• FDA's guidance suggests submitting within 15 calendar days of introducing the version or model to commercial distribution. That is a recommendation, not the rule.

The label dates came from the 2013 UDI final rule and FDA's compliance dates page:

For Class I and unclassified devices other than implantable, life-supporting or life-sustaining ones, FDA's July 2022 guidance deferred enforcement of labeling to 24 September 2022 and of GUDID submission to 8 December 2022. The same guidance says FDA does not intend to enforce GUDID submission for Class I devices that are consumer health products, defined as 510(k)-exempt Class I devices sold over the counter directly to consumers. Class I devices that are exempt from the quality system requirements are excepted from UDI altogether under 801.30(a)(2).

A new DI is required when a change creates a new version or model (830.50(a)) and for any new package configuration (830.50(b)). A labeler keeps its UDI records for three years after it stops marketing the version or model (830.360). A discontinued device's DI cannot be given to another device (830.40(c)).

How labelers submit

FDA lists two routes. One is the GUDID web application, one record at a time. The other is HL7 SPL files sent through FDA's Electronic Submissions Gateway, which suits large catalogs. FDA's guidance, issued 17 December 2024, ties each account to the organization's DUNS number and each record to a labeler DUNS.

A record is Draft, Unpublished or Published. Draft records are not public. An Unpublished record has a publish date in the future. FDA treats the labeler as having met 830.330 on the date the record is saved in the Published state, so a saved draft does not count. Published records have a seven-day editing grace period, after which fields that signal a new DI are locked.

When a device stops being sold, the labeler updates the commercial distribution end date. The record stays in the database and stays searchable. The guidance puts the duty to update discontinued records on the labeler.

Searching AccessGUDID

AccessGUDID offers a basic search by DI, company, brand name, common name, or version or model, and an advanced search. Basic search needs at least three characters and returns at most 1,000 records. A full UDI pasted from a label is parsed to its DI.

Our UDI lookup searches the openFDA copy of the same public records and parses a pasted barcode. openFDA's copy can trail AccessGUDID, so check the newest publish date shown on the tool against AccessGUDID when timing matters.

Neither tool shows records that are Draft or Unpublished, or still in the seven-day grace period. Both show the labeler's data as submitted.

API and bulk downloads

AccessGUDID publishes four download sets:

• a daily file for each business day
• a weekly file
• a monthly update file
• a full release once a month

The 9 November 2026 daily file held 2,944 DI records. The most recent full release, dated 2 November 2026, was 524 MB. Files are XML, and the full release is also offered as pipe-delimited text for loading into a database. The NLM's API (version 3 at the time of writing) offers a device lookup by DI, UDI or record key, and a parse endpoint that splits a UDI string into its DI and production identifiers. The openFDA device UDI endpoint carries the same public records and says it updates weekly.

AccessGUDID's terms of use restrict some content. GMDN terms are licensed from The GMDN Agency, which says that using them to build alternative categorisations or for AI training needs its licence, and Dun & Bradstreet data is for FDA's internal use. Read the terms before you build a product on the files.

How FDA inspects UDI and GUDID

Compliance Program 7382.850 treats UDI as one of four other applicable FDA requirements, alongside medical device reporting, corrections and removals, and tracking. The program has an assignment code for it and tells investigators to evaluate it on all risk-based inspections except PMA preapproval inspections. Before the inspection, reviewers look at the firm's records in GUDID. During it, the program tells the investigator to:

• check that the UDI on the label is available in plain text and in machine-readable form, and ask the firm to confirm the barcode scans
• compare the fields in AccessGUDID with the labeling and the UDI on the device, including the DI information, device characteristics, alternative identifiers and customer contact
• confirm that a discontinued device has its commercial distribution status and end date updated
• review labeling procedures and records under 820.35(c) and 820.45

The QMSR links these to Part 820. Section 820.10(b)(1) says a manufacturer must document a system to assign unique device identification under part 830, as part of ISO 13485 clause 7.5.8. Section 820.35 requires the UDI to be recorded in complaint and servicing records and for each device or batch. Section 820.45(a)(1) requires labeling and packaging to be examined before release for the correct UDI.

UDI also appears on 483s. Among device inspections with posted citations ending from 4 February to 20 October 2026, 18 of 404 cite 21 CFR 801.20(a) (4%), 18 cite 830.300(a) (4%) and 12 cite 830.310(b) (3%). In fiscal year 2025 the shares were 7%, 6% and 1% of 715 inspections. FDA words 830.300(a) as "Devices subject to device identification GUDID data submission requirements". These counts come from scripts/analyze-qmsr-iso-clauses.py. Posted citations are a subset of FDA's 483s. The ISO 13485 clauses post explains the limits.

What a search does not show

• Individual units. Lot, serial number and expiry are not in GUDID, so a record cannot tell you whether a given unit was part of a recall. Medical device reports and correction and removal reports carry the UDI of the affected product instead (803.52 and 806.10(c)(5)).
• Accuracy. The labeler submits the data. FDA can delete or correct information it finds incorrect or misleading (830.350), and its guidance says labelers must keep records accurate. We found no FDA statement that it verifies each record.
• Sales. A record exists whether or not any units were sold.
• Hidden fields. The FDA listing number and company address are withheld.
• Current status. A device that left the market stays in the database. Check the commercial distribution status and end date.
• Your submission. Records still in Draft, or in the seven-day grace period, do not appear.
• The EU. EUDAMED is a separate database with a Basic UDI-DI. See the entry on EU MDR.