FDA – Medical Devices
UDI / GUDID
Fee: Request a quote
In the United States, the label and packaging of every medical device carry a unique device identifier (UDI), with limited exceptions. The UDI is issued under the system of an FDA-accredited issuing agency. The labeler submits the device data for each model electronically to FDA’s GUDID database.
Who Is Obligated?
Domestic and foreign companies that are the labeler of devices required to carry a UDI.
What We Do
- We assess which products must carry a UDI and which are excepted.
- We guide you in choosing the issuing agency and structuring the code.
- We set up the GUDID account and submit the model data on your behalf.
What You Receive
- GUDID records
- UDI label checklist
UDI and GUDID Registration Application
Labeler, account and model details for assigning UDI codes to your devices and entering them in the FDA GUDID database.
Frequently Asked Questions
- Does every device need to carry a UDI?
- Yes, with limited exceptions; in the United States the label and packaging of every medical device carry a UDI. We assess which of your products fall under an exception.
- Who issues the UDI?
- The UDI is issued under the system of an FDA-accredited issuing agency. We guide you in choosing the agency and structuring the code.
- Who enters the data in GUDID?
- The labeler submits the device data for each model to GUDID. We set up the GUDID account and submit the model data on your behalf; this requires a DUNS number.
Sources: 21 CFR 801.20; 21 CFR 830.20; 21 CFR 830.300; 21 CFR 830.320.