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FDA UDI and GUDID Compliance Solutions
Under the FDA Unique Device Identifier (UDI) rule, most medical device labels and packages must bear a UDI. The device labeler must apply the UDI and submit device information, including a device identifier (DI), product codes, and other characteristics to the Global Unique Device Identification Database (GUDID).
The UDI deadlines for most devices have passed.
Get Expert Assistance
Registrar Corp’s Regulatory Specialists can guide you through FDA UDI and GUDID requirements.
What is a UDI?
A UDI is a human-readable and machine-readable code used to identify a specific medical device from a specific device labeler. Numbers in parentheses delimit meaningful aspects of the numeric or alphanumeric code.
Two main components define a UDI:
Device Identifier (DI)
A DI defines the labeler as well as the device version or model. The DI is used as a primary key to reference this information in GUDID.
Production identifier (PI)
A PI defines characteristics such as:
- Manufacturing / Production Date
- Expiration Date
- Batch / Lot Number
- Serial Number
Steps to UDI Compliance
1. Obtain a DUNS number
A device labeler complying with UDI requirements is required to have a DUNS number, which is used to identify the labeler in GUDID.
2. Appoint A Regulatory Contact
FDA requires device labelers to designate a point of contact for device information. This Regulatory Contact ensures that required UDI information is submitted to FDA via GUDID.
3. Gather Your UDIs
UDIs have a device identifier (DI) and a production identifier (PI). The DI must be issued by an FDA accredited agency. The PI is determined by production information, such as the lot or batch number. A separate UDI is needed for every version or model of each device.
4. Identify GMDN codes
Device labelers are required to identify a Global Medical Device Nomenclature (GMDN) code for each device submitted to the GUDID. A GMDN code represents an international standard for describing a specific device.
5. Submit Device Information to GUDID
UDIs and all required device information must be submitted through to FDA through GUDID.
How Many UDIs Are Necessary?
A single device type needs a separate UDI for each different device characteristic, including:
Size • Color • Material • Style • Packaging
Registrar Corp Makes Compliance Easy
Registrar Corp offers simple, low-cost solutions for FDA UDI and GUDID requirements.
Choose Registrar Corp for:
One-on-one guidance from a regulatory specialist
Guidance on required data
Submission-ready data for your device
Submission of your UDIs to GUDID
