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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.
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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
