UDI Basics | FDA - U.S. Food and Drug Administration
How do I recognize a UDI on a label? Developing a UDI using an FDA-accredited issuing agency’s system; Meeting compliance dates and requirements
Unique Device Identification System (UDI System) | FDA
When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize...
Unique Device Identification (UDI) - Healthcare - GS1
Feb 20, 2025 · According to the U.S. FDA, when fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernise device postmarket surveillance, and facilitate medical device innovation.
The US FDA requires labelers to follow the rules of their UDI Issuing Agency... this is part of GS1’s Scope & Standards!
UDI Compliance Policies and UDI Rule Compliance Dates | FDA
Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements, including the prohibition on the use of certain legacy FDA identification numbers (National...
eCFR :: 21 CFR Part 830 -- Unique Device Identification
Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20. A UDI is composed of: (1) A device identifier —a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and.
UDI Labeling (Unique Device Identification): Best Practices
Jul 30, 2020 · What is UDI labeling? UDI is medical device identification comprised of a Device Identifier (DI) and Production Identifier (PI) per an approved Issuing Agency that allows the unambiguous identification of a specific device on the global market.
Mar 24, 2017 · A UDI code aims at unambiguous identification of a specific medical device. To ensure a globally standardized and harmonized system, the UDI code must be issued under the rules of a U.S. FDA-accredited issuing agency or an EU-accredited assigning agency, which includes GS1. The UDI code is a unique, alphanumeric code, which consists of two parts:
A Guide To UDI Device Label And Package Requirements - Med …
Nov 24, 2014 · On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you have selected, and make sure they are both machine‑readable and human‑readable.
The label and device package of each medical device must now include a UDI. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The UDI shall be on the label of the device or directly marked on the device