Medical Devices

Unique Device Identification - UDI

FDA Proposes to End Temporary Extension of GUDID’s Grace Period

On December 18, 2018, the U.S. Food and Drug Administration (FDA) issued the public notice and opened a docket for comments, “Unique Device Identification System: Grace Period Change and Proposed Modifications to the Global Unique Device Identification Database (GUDID).”

In September 2014, a temporary change was made to the Global Unique Device Identification Database (GUDID) to extend the grace period from seven to 30 calendar days when Device Identifier (DI) records are submitted.

The FDA is proposing to end the temporary extension and revert back to the original grace period of seven calendar days beginning in 2019.

The FDA requests input on this proposal. You may submit comments to the public docket at www.regulations.gov using docket number FDA-2018-N-4673 or by clicking the button below. Please submit comments for consideration by January 18, 2019.

Submit Comments

The 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 the 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**

*Policy in recent FDA guidance is applicable to direct marking of certain class II devices manufactured and labeled prior to September 24, 2018,

**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: 12/19/2018
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