GUDID Device Registration
What is GUDID?
The Global Unique Device Identification Database (GUDID) is a database provided by the FDA with the purpose of centralizing and making accessible key medical device information for every device with a unique device identifier (UDI) on its label.
Who is responsible for submitting device data to GUDID?
Labelers are responsible for UDI labeling on the device as well as submitting the required device data to the GUDID.
Who is considered a labeler?
According to the FDA, a labeler is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.
The addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler.
In most instances, the labeler is the device manufacturer, but the labeler may be a specification developer, a single-use device re-processor, a convenience kit assembler, a re-packager, or a re-labeler.
Does the requirement apply to foreign (non-US) medical device manufacturers and labelers?
The FDA UDI rule applies to all medical devices that are sold in the US. If you are a foreign labeler with medical devices sold in the US, the UDI requirements, including the need to submit device data to the GUDID, will apply to you.
What are the key dates for GUDID submission?
The GUDID submission timelines are as follows based on the Medical Device Type and Risk Class:
- Class III Medical Devices & Devices Licensed under the Public Health Service Act – September 24, 2014
- Implantable, Life-Supporting & Life Sustaining Medical Devices – September 24, 2015
- Class II Medical Devices – September 24, 2016
- Class I & Unclassified Medical Devices – December 8, 2022
What is a Grace Period?
Grace Period is a time window after the DI Record Publish Date which is intended for labelers to have the opportunity to review and correct data of published Device Identifier (DI) records in the GUDID before they are made available to the public. The grace period begins the day after a device’s GUDID DI Record Publish Date and is currently set at 7 days. During the grace period, labelers may edit and correct all data elements for the DI record. Once the grace period expires, certain data elements can no longer be added, edited or deleted.
Is there any way to correct data after the Grace Period?
Yes, the FDA introduced a feature in March 2018 for a GUDID Coordinator user to “unlock” device records in the GUDID Web Portal to make error corrections for Published device records after their grace period. The records that are unlocked will remain unlocked for 5 calendar days (starting the day after the record is unlocked). Corrections to these records can be done via the GUDID web interface or M2M via the GUDID HL7 SPL submission option. Records will be locked again once the edits that are submitted are correctly processed (or after completion of the 5 calendar day unlock period, whichever is earlier). Updated information will be released to public users on AccessGUDID and OpenFDA on the next scheduled release date. All prior published versions of a given record will remain accessible on AccessGUDID and OpenFDA as device record history.
Did You Know?
26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.
What’s the difference between a Device Identifier and a Production Identifier?
UDI is made up of both Device Identifier (DI) and Production Identifier (PI).
- Device identifier (DI) is a static identifier that identifies the labeler and a specific version or model of a device.
- Production identifier (PI) is a dynamic identifier that is variable depending on the specific production of the device. It can be a lot/batch number, serial number, expiration date, manufacturing date or distinct identification code (for a human cell, tissue, or cellular and tissue-based products that are regulated as a device).
Medical devices need to be a labeled with a UDI containing both the Device Identifier (DI) and Production Identifier (PI) in human and machine-readable form.
Do I need to submit the Production Identifier to the GUDID?
No. GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the primary key to obtain medical device information in the database. The Production Identifiers (PIs) do not need to be submitted to GUDID. However, you need to submit to GUDID what types of Production Identifier will be used for the control of the device (i.e. a lot/batch number, serial number, expiration date, manufacturing date or distinct identification code)
How can Innovit help?
Innovit is the leading provider of UDI data compliance solutions and has enabled several global device manufacturers and labelers to meet their UDI compliance deadlines by providing a direct connector to the GUDID for M2M data submission or via our GDSN Multi-Connector for customers who prefer using GDSN as the standard for submitting their data.
Try out our GUDID playground solution or contact our GUDID experts to get started.