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  1. Device Advice: Comprehensive Regulatory Assistance

Unique Device Identification System (UDI System)

News and Updates

In May 2021, the FDA issued the guidance Enforcement Policy Regarding Use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) Numbers on Device Labels and Packages. The guidance explains that the FDA does not intend to object to the use of legacy NHRIC and NDC numbers on device labels and device packages for finished devices that are manufactured and labeled prior to September 24, 2023.

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

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 device postmarket surveillance, and facilitate medical device innovation.


Access GUDID Identify Your Medical Device

Search the AccessGUDID Database

AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, and premarket submission numbers. AccessGUDID is available for anyone, including patients, care givers, health care providers, hospitals, and industry.

Search AccessGUDID


Unique Device Identifier (UDI) Label Sample

Device Labelers: Comply with UDI Requirements

In general, the UDI final rule requires device labelers (typically, the manufacturer) to:

  1. Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency’s UDI system, on device labels, device packages, and in some instances, directly on the device.
  2. Submit device information to the Global Unique Device Identification Database (GUDID).

Start Here: UDI Basics


GUDID Global Unique Device Identification Database

Device Labelers: Submit Data to GUDID

The FDA provides device labelers with two options for submitting data to GUDID: manual data entry using the GUDID web application (for entering data for one device at a time) and HL7 SPL submission via FDA Electronic Submissions Gateway (for bulk uploads). For details on each option, see Submit Data to GUDID.

Log In to GUDID


 



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