UDI and GUDID Submission
A unique device identifier is a code that appears on your device label and identifies the version or model.
A record for each device is published in FDA's Global Unique Device Identification Database, known as GUDID.
Published records are searchable by anyone through AccessGUDID.
We create and publish those records for you, and confirm that the identifier printed on your labeling matches them.
At a glance
| What it is | A device identifier on your label, and a published record for each device in FDA's GUDID database. |
|---|---|
| Who is responsible | The labeler — whoever causes the label to be applied, including manufacturers, specification developers, repackagers and relabelers. |
| The two parts of a UDI | Device identifier, which is mandatory and fixed. Production identifier, which is conditional and varies — lot, serial, expiry or manufacturing date. |
| Where the number comes from | An FDA-accredited issuing agency. That is a separate organization and a separate cost, paid to them and not to FDA or to us. |
| Is it public | Yes. Published records are searchable by anyone through AccessGUDID. |
| Our fee | Quoted per submission batch. Send your device list. |
What we do
- Confirm which of your devices require GUDID records.
- Assemble the required data elements for each device.
- Create and publish the records in GUDID.
- Check that the identifier on your artwork matches the published record.
- Update records when a device changes, is discontinued, or a new version is released.
Why your customers ask for this
GUDID records are public. Hospitals, distributors and group purchasing organizations use AccessGUDID to confirm that a device is what the supplier says it is.
A device with no published record is difficult for a hospital procurement system to accept, even when the underlying compliance is complete. For most companies the first pressure to comply arrives from a customer, not from FDA.
Questions people ask
Who is the labeler if we manufacture for another company's brand?
The labeler is whoever causes the label to be applied with the intent that the device is commercially distributed. For a device sold under another company's brand, that responsibility usually sits with them rather than with you. Confirm it in writing before either party assumes the other is handling it.
Does every device need a UDI?
Requirements depend on device class and there are exceptions. We confirm which of your devices are covered before quoting.
Do we get the identifier from FDA?
No. Identifiers come from an FDA-accredited issuing agency, which is a separate organization with its own fee.
What happens if our records are wrong?
They are public, so an error is visible to your customers and to FDA. Records can be corrected. We audit your existing GUDID entries against FDA's published data as part of taking on a new client, and tell you what we find before you commit to anything.