SEMPERGRAMS
January 17, 2020
Enforcement of UDI Labeling
On September 24, 2013, the Food and Drug Administration (FDA) established a unique identification system to adequately identify medical devices. The label of most devices must include a Unique Device Identifier (UDI) in human-and-machine readable format.
Enforcement of UDI labeling and data submission for Class 1 medical devices, including disposable surgical and examination gloves, will begin on September 24, 2020. To meet this compliance date, Sempermed has already labeled our products with a UDI, in the form of 12 and 14 digit Universal Product Codes (UPC), which were created using GTIN (barcoding) software provided by GS1.
There is still much confusion over the terms UDI, GTIN and GS1. In summary, GTIN (Global Trade Item Number) is an item barcoding system developed by the non-profit organization GS1. GTIN identifiers are among the recognized types of barcodes that the Food and Drug Administration (FDA) accepts for their UDI program. GS1 is an FDA-accredited issuing agency.
In order to be compliant, the labeler must submit information concerning each device to FDA’s Global Unique Device Identifier Database (GUDID), which serves as the repository of key device identification data. The labeler is most easily defined as the owner of the brand. The owner of a private label brand is therefore the labeler. All such devices must be properly labeled with a UDI and be registered on GUDID by September 24, 2020.
If you would like more information about the UDI program it is available in a FAQ document, which can be downloaded from the following web address:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf
If you would like more information about GS1 or GTIN it is available from the following web address:
https://www.gs1us.org/what-we-do/about gs1us?_ga=2.56170786.825423962.1571935147-1197410870.1551886429
https://www.gs1us.org/education-training/frequently-asked-questions/gs1-company-prefix-barcodes-and-identification
At Sempermed, we care about your comfort and protection, always. It is the driving force behind what we do. Our gloves are disposable. The people we protect are not®.
Enforcement of UDI labeling and data submission for Class 1 medical devices, including disposable surgical and examination gloves, will begin on September 24, 2020. To meet this compliance date, Sempermed has already labeled our products with a UDI, in the form of 12 and 14 digit Universal Product Codes (UPC), which were created using GTIN (barcoding) software provided by GS1.
There is still much confusion over the terms UDI, GTIN and GS1. In summary, GTIN (Global Trade Item Number) is an item barcoding system developed by the non-profit organization GS1. GTIN identifiers are among the recognized types of barcodes that the Food and Drug Administration (FDA) accepts for their UDI program. GS1 is an FDA-accredited issuing agency.
In order to be compliant, the labeler must submit information concerning each device to FDA’s Global Unique Device Identifier Database (GUDID), which serves as the repository of key device identification data. The labeler is most easily defined as the owner of the brand. The owner of a private label brand is therefore the labeler. All such devices must be properly labeled with a UDI and be registered on GUDID by September 24, 2020.
If you would like more information about the UDI program it is available in a FAQ document, which can be downloaded from the following web address:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf
If you would like more information about GS1 or GTIN it is available from the following web address:
https://www.gs1us.org/what-we-do/about gs1us?_ga=2.56170786.825423962.1571935147-1197410870.1551886429
https://www.gs1us.org/education-training/frequently-asked-questions/gs1-company-prefix-barcodes-and-identification
At Sempermed, we care about your comfort and protection, always. It is the driving force behind what we do. Our gloves are disposable. The people we protect are not®.
