UDI System — Unique Device Identification Requirements (21 CFR Parts 801 and 830)
FDA's Unique Device Identification (UDI) system, implemented under 21 CFR Parts 801 and 830, requires all medical device labels and packages to bear a UDI consisting of a Device Identifier (DI) and a Production Identifier (PI). The UDI must appear in both human-readable and machine-readable (barcode) format using an FDA-accredited issuing agency standard (GS1, HIBCC, or ICCBBA).
Manufacturers must also submit device and labelling information to the Global Unique Device Identification Database (GUDID), publicly searchable at accessgudid.nlm.nih.gov.
Key milestones (phased implementation — now complete for all classes):
- Class III devices: Completed
- Class II devices: Completed
- Class I devices and devices exempt from 510(k): Completed
📅 Effective / published: UDI rule finalised 2013; all phases now in force
Manufacturers placing new devices on the US market must obtain a UDI from an accredited issuing agency, apply the UDI to device labels and packages at all levels, and submit GUDID data before commercial distribution. Ensure GUDID submissions are kept current — changes to labelling, device versions, or discontinuations require GUDID updates.
View official source (FDA — UDI System) ↗