Medical Devices

Unique Device Identification - UDI

FDA has established and continues to implement a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the GUDID at AccessGUDID.

The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.

Access GUDIDAccessGUDID is the public portal for the GUDID data submitted to the FDA by the labelers. AccessGUDID features include simple search, advanced search, web services/APIs and downloads.
GUDID Quality IconGUDID data quality is imperative as these data are posted for the public and for use in downstream systems. To fully reap the public health benefits and a return on investment of the UDI system, FDA is focusing its UDI resources on optimizing the quality and utility of UDI data. FDA is committed to working with industry to ensure widespread use and sustainability of the UDI system.
GUDID AnalyticsGUDID Analytics is a collection of presentation files that show patterns and trends in the GUDID data. The GUDID analytics presentation files are updated monthly and are available for download and use.

 

September 24, 2018 is:

  • The UDI compliance date for direct marking of class II devices
  • The date the UDI will be required for most kits with at least one class III, I/LS/LS or class II device within the kit
  • The date the UDI will be required for most co-packaged and cross-labeled combination products with a device constituent
  • The expiration date of the 801.30(a)(1) (three year "grandfather") I/LS/LS inventory exception
  • The UDI compliance date for class I/unclassified devices for labeling and GUDID submissions**

**The FDA issued guidance stating the agency intends not to enforce the class I/unclassified device compliance dates for two years (two year period ending September 24, 2020 for labeling and GUDID submissions; September 24, 2022 for direct marking). 

If you have a question or concern you’d like to share with the UDI team, please contact the FDA UDI Help Desk.

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Page Last Updated: 05/07/2018
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