UDI and GUDID
A Unique Device Identifier is a code that identifies a device through its distribution and use. The label of every medical device must bear one, and every device package must bear one. The device identifier portion is then submitted to the Global Unique Device Identification Database, FDA's public reference catalog, where anyone can look it up.
21 CFR 830; 21 CFR 801 subpart B
At a glance
| Who is responsible | The labeler — whoever causes a label to be applied, or causes it to be replaced or modified, with the intent that the device will be commercially distributed. |
|---|---|
| Two parts | A device identifier (DI) and, conditionally, a production identifier (PI). |
| Device identifier | Mandatory and fixed. Identifies the version or model, and the labeler. |
| Production identifier | Conditional and variable. Lot or batch, serial number, expiration date, manufacturing date, or an HCT/P distinct identification code. |
| Where numbers come from | An FDA-accredited issuing agency. FDA has accredited three: GS1, HIBCC and ICCBBA. |
| The database | GUDID holds only the DI portion. It is public through AccessGUDID. |
| The regulations | 21 CFR 801.20, 801.30, 801.40, 801.45, 801.50, 801.55 and 801.57, plus Part 830. |
| Class I devices | The UDI of a Class I device is not required to include a production identifier. |
"Labeler" is broader than "manufacturer"
The regulation defines a labeler as any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any intended subsequent replacement or modification of the label. It also covers any person who causes the label to be replaced or modified with that same intent.
This brings in more parties than the word "manufacturer" does. A repackager, a relabeler and a specification developer can all be the labeler for a given device.
One narrow carve-out: adding the name and contact information of a person who distributes the device, without making any other change to the label, is not a modification for the purposes of deciding who the labeler is.
DI and PI
Mandatory and fixed: the device identifier identifies the specific version or model of a device, and the labeler of that device. It is the key that retrieves the record in GUDID.
Conditional and variable: the production identifier. The condition is set by what already appears on the label — whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or an HCT/P distinct identification code, the UDI must include a production identifier segment conveying that information.
So the production identifier is not a separate decision. It follows from what the label already carries.
A UDI must be issued under a system operated by FDA or by an FDA-accredited issuing agency. FDA has accredited three: GS1, the Health Industry Business Communications Council, and ICCBBA. The issuing agency is a separate organization with its own fee, paid to it rather than to FDA.
Exemptions from UDI
The regulation lists eleven general exceptions. The ones that matter most in practice:
- A Class I device that FDA has exempted by regulation from the good manufacturing practice requirements of Part 820.
- Individual single-use devices, all of a single version or model, distributed together in a single device package. This exception is not available for any implantable device.
- A device used solely for research, teaching or chemical analysis, and not intended for any clinical use.
- A custom device, an investigational device, or a veterinary medical device.
- A device intended for export from the United States.
- A device packaged within the immediate container of a combination product or convenience kit, where the outer label bears a UDI.
Shipping containers do not require a UDI.
Questions people ask
Who can see our GUDID record?
Anyone. AccessGUDID is available to patients, caregivers, healthcare providers, hospitals and industry. It is a public database.
Does GUDID contain the production identifier?
No. GUDID contains only the device identifier. It carries PI flags indicating which production identifier attributes are part of the UDI, but not the values themselves.
Do we need a UDI if our device is exempt from 510(k)?
Exemption from premarket notification is unrelated to UDI. The UDI requirement applies to the label of every medical device unless one of the exceptions in 21 CFR 801.30 applies.
Can we use our existing GS1 barcodes?
GS1 is one of the three FDA-accredited issuing agencies, so a GS1 identifier issued under its UDI system can serve. Whether existing barcodes meet the UDI format requirements in 21 CFR 830.20 is a separate question.
What if we cannot meet a requirement?
21 CFR 801.55 sets out how to request an exception from, or an alternative to, a UDI requirement.