Tracker entry M32: FDA UDI for medical devices
In force
US
- Region
- US
- Sector
- Healthcare
- Imposed by
- FDA
- Applies to
- Medical device labellers
- Technology
- RFID one option
What the rule requires
Device labels and packages must carry the UDI in plain text and in a machine-readable (AIDC) form. The rule is technology neutral, so a barcode, RFID or NFC tag all qualify, but if the AIDC carrier is not visible, as with RFID, the label must say that AIDC is present (21 CFR 801.40(c)). In practice barcodes dominate and RFID is an optional extra.
Status: In force; all statutory compliance dates have passed, the last FDA enforcement pause ended in Dec 2022
What it means for RFID
For RFID the FDA UDI rule is permissive rather than demanding. Device labellers may use RFID or NFC as the machine-readable carrier for the UDI alongside the plain-text version, but nothing in the rule requires a tag, and barcodes remain the usual choice.
Labellers that do choose RFID have one specific obligation: because the tag cannot be seen, the label must state that AIDC is present, under 21 CFR 801.40(c). Tag suppliers and integrators working with device makers should build that statement into label designs.
There is no further milestone to watch. All statutory compliance dates have passed, and the last FDA enforcement pause ended on 8 December 2022.
Timeline
- UDI final rule published
- Class III devices: UDI on label and GUDID data
- Implantable, life-supporting and life-sustaining devices: label, GUDID and direct mark
- Class II devices: UDI on label and GUDID data; Class III direct mark
- Class I and unclassified devices: statutory label and GUDID date; Class II direct mark
- Class I and unclassified devices: statutory direct mark date
- FDA enforcement pause ends for Class I and unclassified labelling and direct marking
- FDA enforcement pause ends for Class I and unclassified GUDID submission
- Legacy NDC and NHRIC numbers no longer allowed on devices labelled from this date
Sources
Official source: FDA
Last checked against the official source on 29 October 2026.
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