The UDI deadline for Class I devices passes in
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.
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.
METTIFDA Regulatory Specialists can guide you through FDA UDI and GUDID requirements.
"*" indicates required fields
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 |
 |
 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.
|
|
METTIFDA 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 |
