U.S. FDA Registration & Labeling Compliance Assistance

FDA GUDID/UDI Compliance for Medical Devices

The FDA has started the Unique Device Identification (UDI) system to identify and track all medical devices marketed in the United States. The FDA's UDI rule requires device labelers, typically manufacturers or brand owners, to include a UDI on device labels and packages.

As of September 24, 2022, labelers of all device classes I, II, and III sold in the U.S. must submit their device information on the FDA Global Unique Device Identification Database (GUDID) and obtain the UDI. The FDA system also considers limited UDI exceptions and alternatives.

Key Components of UDI:

• To generate UDIs, labelers of devices must submit the device information to GUDID. 

• UDI is a unique code consisting of a Device Identifier (DI) and a Production Identifier (PI) portions created in human and machine-readable format.

• The DI is a mandatory part of a UDI issued by an accredited FDA agency and includes a fixed portion that identifies the labeler and device version or model.

• The PI is provisional and includes a variable portion that identifies device specifications or production details, such as manufacturing and expiration date, serial number, batch, or lot number, etc., which can facilitate the search in the GUDID database.

Steps for UDI Submission:

1. Obtain the DUNS number & validate labeler information
2. Assign regulatory contact & request GUDID account
3. Verify GMDN standard codes & create UDIs
4. Submit UDIs & device information on GUDID

 GUDID Database:

The FDA administers the Global Unique Device Identification Database, known as Access-GUDID, an extensive catalog for all devices featuring a unique device identifier (UDI). GUDID exclusively contains the device identifier (DI) portion of the UDI, serving as the primary means to access device information in the database. Although GUDID doesn't encompass production identifiers (PIs), it does include PI flags to indicate which PI attributes are present in the UDI. Moreover, the AccessGUDID Database, a universal UDI database, includes the Global Medical Device Nomenclature (GMDN) Code, specifying its status as Active or Obsolete.

FDA Listing Inc. is committed to assisting companies in meeting the FDA's UDI requirements and facilitating timely and successful data submission to GUDID. Feel free to call or email us.