Usage Examples
- The device identifier record has to be live in GUDID before that label ships, not after.
- That design change creates a new model, so it needs a new device identifier, not an edit to the existing one.
- Direct marking is not technologically feasible on this handle, so document the exception in the design history file.
What is UDI (Unique Device Identification)?
UDI is the unique numeric or alphanumeric code FDA requires on medical device labels to identify a device through its distribution and use, built from a fixed device identifier plus a conditional production identifier.
UDI exists to identify medical devices sold in the United States from manufacturing through distribution to patient use, which nothing on a device label reliably did before. FDA's Unique Device Identification System final rule, published 24 September 2013, obliges the labeler, usually the manufacturer, to carry one standardized identifier on the label and to file that identifier with FDA in a public database.
UDI covers the label and every device package of a finished medical device, plus a permanent direct marking on devices that are reused after reprocessing, and stand-alone software regulated as a device. UDI does not cover shipping containers, custom devices, investigational devices under part 812, research or teaching devices, devices intended for export, or Class I devices FDA has exempted from part 820 good manufacturing practice.
UDI is applied in practice as two linked workstreams. The labeler obtains a device identifier from GS1, HIBCC, or ICCBBA, prints it with any production identifier in both plain text and machine-readable AIDC form, then submits a device identifier record to GUDID no later than the date the label must bear the UDI. Any change producing a new version, model, or device package forces a new device identifier.
Not to be confused with
- GUDID
- GUDID is the FDA database that stores UDI data, not the identifier itself. GUDID holds only the device identifier portion of the UDI; production identifiers never enter the database, only flags recording which production identifiers appear on the label.
- Device identifier (DI)
- the DI is the mandatory, fixed half of a UDI that names the labeler and the specific version or model. A full UDI is the DI plus a conditional production identifier, so a DI on its own is not a compliant UDI where the label carries lot, serial, manufacturing date, or expiration date.
- NDC and NHRIC numbers
- legacy FDA identification numbers that the UDI rule rescinds rather than coexists with. On the date a device must bear a UDI, any NDC or NHRIC assigned to it is rescinded and may no longer appear on the label or any device package.
- Device labeling
- labeling is the whole body of information accompanying a device, including instructions for use and warnings. UDI is one identifier that must appear on the label and package, and satisfying UDI requirements discharges none of the other labeling obligations.
UDI obligations sit on the labeler, which is whoever causes the label to be applied, not necessarily the legal manufacturer.
What you must do
- 1Obtain the device identifier from a system operated by FDA or an FDA-accredited issuing agency, and confirm the UDI conforms to ISO/IEC 15459-2, 15459-4 and 15459-6 and uses only the invariant character set of ISO/IEC 64621 CFR 830.20
- 2Place a UDI on the label of every medical device and on every device package21 CFR 801.20
- 3Present the UDI in two forms, easily readable plain text and automatic identification and data capture technology, and include a production identifier segment whenever the label carries a lot or batch number, serial number, manufacturing date, or expiration date21 CFR 801.40
- 4Permanently mark the UDI on the device itself when the device is intended to be used more than once and reprocessed before each use, and if an exception applies, document the basis of that decision in the design history file21 CFR 801.45
- 5Submit the device identifier record to GUDID no later than the date the label must bear the UDI, then update it no later than the date the device is first labeled with the changed information, or within 10 business days when the changed information does not appear on the label21 CFR 830.330
Common mistakes
Editing a device identifier record instead of issuing a new one
A change that produces a new version or model, or a new device package, requires a brand new device identifier, and a discontinued model's identifier may never be reassigned to another device. Editing the existing record instead collapses two physically different products onto one identifier, which is the exact failure the UDI system was built to remove.
Treating GUDID submission as a launch task that is then finished
The record must be updated no later than the date the device is first labeled with the changed information, and within 10 business days when the change does not appear on the label. FDA can also delete or correct GUDID data on its own initiative, and gives the labeler only 30 days to respond to a correction notice before acting.
Leaving an NDC or NHRIC number on device artwork
FDA's enforcement policy on legacy identification numbers covered only finished devices manufactured and labeled before 24 September 2023, so anything labeled on or after that date must comply with the rescission in 21 CFR 801.57. Combination products are where this bites hardest: one that properly bears an NDC number is not subject to 21 CFR 801.20 at all, while its separately packaged device constituents usually are. FDA's dedicated guidance on UDI requirements for combination products remains a draft, issued 26 June 2025 under docket FDA-2025-D-0176, so it is not binding on anyone today.
When This Matters
- The device identifier record has to be live in GUDID before that label ships, not after.
- That design change creates a new model, so it needs a new device identifier, not an edit to the existing one.
- Direct marking is not technologically feasible on this handle, so document the exception in the design history file.
Frequently Asked Questions
UDI labeling deadlines have all passed. Class III devices had to bear a UDI by 24 September 2014, implantable, life-supporting and life-sustaining devices by 24 September 2015, Class II by 24 September 2016, and Class I and unclassified devices by 24 September 2018. Direct-marking and GUDID dates followed each class.
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