FDA GUDID and Unique Device Identifier (UDI) for Medical Devices
Who must register with the FDA?
- FDA has established a unique device identification system to adequately mark and identify medical devices through their distribution and use (in human readable plain text and machine readable formats like AIDC technology). A UDI is required on device labels and device packages, and in some cases on the devices themselves, unless there is an exception or alternative granted by the FDA. The UDI needs to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed between uses. The permanent UDI may be in plain text, AIDC technology, or both.
- The label of every medical device (including all IVDs) must have a UDI, Class I cGMP exempt devices do not need to be labeled with a UDI.
- Every device package must have a UDI.
- Devices within co-packaged combination products that bear an NDC are required to bear a UDI on its label.
- Stand-alone software must bear a UDI on its label and device packages as well as on a startup screen.
The UDI is composed of two parts, Device Identifier (DI) and Product Identifier (PI).
DI (Mandatory, fixed portion of UDI):- DI identifies the labeler and the specific version or model of a device- DI assigned to a specific Medical Device version or model never changes.- New DI is required for new version or model
PI (Conditional, variable portion of UDI):
- PI will change for each lot or batch- When certain information is on the label it should be in the UDI as well. (except for Class 1 devices)- PI includes lot, batch, serial number, expiration date, date of manufacture, and distinct identification code (If any)
FDA has accredited three Issuing Agencies (GS1, HIBCC and ICCBBA) that conform to international standards to assign UDI. Labelers can contact any accredited Issuing Agency to get the UDI. The fees for UDI assignment for each agency is different.
GUDID Sumbission
The GUDID (Global Unique Device Identifier Database) is a database which contains device identification information. The GUDID contains only the DI portion of UDI. PI parts are not submitted to or stored in the GUDID.
The compliance dates for GUDID submissions are as follows:
(1) Class III medical devices which includes stand –alone software - September 24, 2014(2) Implantable, life supporting and life sustaining devices which includes stand-along software - September 24, 2015(3) Class III reusable devices that are required to have UDI on the device itself, Class II devices - September 24, 2016(4) Class II reusable devices that are required to have UDI on the device itself, Class I which includes stand-alone software and Unclassified devices - September 24, 2018(5) Class I reusable devices that are required to have UDI on the device itself - September 24, 2020(6) For Class I and unclassified devices manufactured and labeled on or after September 24, 2018 - September 24, 2022(7) For Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 – September 24 , 2022
(1) Class III medical devices which includes stand –alone software - September 24, 2014(2) Implantable, life supporting and life sustaining devices which includes stand-along software - September 24, 2015(3) Class III reusable devices that are required to have UDI on the device itself, Class II devices - September 24, 2016(4) Class II reusable devices that are required to have UDI on the device itself, Class I which includes stand-alone software and Unclassified devices - September 24, 2018(5) Class I reusable devices that are required to have UDI on the device itself - September 24, 2020(6) For Class I and unclassified devices manufactured and labeled on or after September 24, 2018 - September 24, 2022(7) For Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 – September 24 , 2022
FDA GUDID and UDI Compliance for Medical Devices Process Cost: $594
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to collect additional company and medical device details
Step 3
Verify DUNS & Labeler Prefix Credentials
Step 4
Regulatory Contact Assignment & GUDID Account Request. Device Data & Class Verification
Step 5
UDI Submission on GUDID