GS1 Company Prefix Identification For Unique Identification of Medical Devices
Across the supply chain, unique product identification is the basis for efficiency and visibility. This identification is even more imperative when it comes to healthcare products, like medical devices, to help increase patient and consumer safety. That is why the U.S. Food and Drug Administration (U.S. FDA) established the unique device identification (UDI) system to adequately identify medical devices sold in the United States.
The U.S. FDA requires GS1 US, a UDI accredited issuing agency, to indicate if a GS1 Company Prefix will or will not be used to identify a medical device.
Below are answers to some frequently asked questions to help you better understand why we are asking this, what the U.S. FDA considers a medical device, and how this information will be used.
Frequently Asked Questions
What does the U.S. FDA consider to be a medical device?
The U.S. FDA requires GS1 US, a UDI accredited issuing agency, to indicate if a GS1 Company Prefix will or will not be used to identify a medical device.
Below are answers to some frequently asked questions to help you better understand why we are asking this, what the U.S. FDA considers a medical device, and how this information will be used.
Frequently Asked Questions
What does the U.S. FDA consider to be a medical device?
The U.S. FDA considers a product to be a device if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. Learn more about the definition at the U.S. FDA’s website.
What are some examples of medical devices?
What are some examples of medical devices?
Per the U.S. FDA, medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters. Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.
What is a UDI accredited issuing agency?
What is a UDI accredited issuing agency?
As an accredited Unique Device Identifier (UDI) Issuing Agency of the U.S. Food and Drug Administration (U.S. FDA), GS1 identifiers issued by GS1 US can be used by a labeler (as defined in the relevant U.S. regulations) to identify medical devices marketed in the U.S. Under the applicable U.S. regulations, GS1 is required to maintain a list of labelers that use its system for the assignment of Unique Device Identifiers (UDIs) and monitor a labeler’s use of the system for assignment of UDIs, specifically regarding the product master data registered in the U.S. FDA UDI Global Unique Device Identification Database or ‘GUDID’.
What is a GS1 Company Prefix?
What is a GS1 Company Prefix?
A GS1 Company Prefix is a unique identification number licensed just to your company— it is a part of every GS1 barcode and GS1 identification number you create for your products, including your Global Trade Item Number® (GTIN®). For this request, we are asking for just your GS1 Company Prefix.
How can I find a list of our GS1 Company Prefixes?
How can I find a list of our GS1 Company Prefixes?
When logged into myGS1US, you can click on the “Verify Prefix Use” tile to review a list of your prefixes and indicate if you are or are not using your prefixes to identify medical devices.
What will you do with the information I provide?
What will you do with the information I provide?
If a licensed GS1 Company Prefix (GCP) is currently used or may be used at any time to create a regulated unique identifier for medical devices (UDI), GS1 US:
- Is under a regulatory obligation to share the GCP and company name with the relevant regulator and bears no liability for the consequences of any information provided by the company that is found to be inaccurate or incomplete, and
- GS1 US reserves the right to modify the use (incl. suspension and revocation of the license) of the GCP for UDI implementation in the relevant jurisdiction, as a follow-up action taken in cooperation with the relevant regulator, in case of repeated and/or deliberate misuse of the GS1 Standards related to UDI.
- Is under a regulatory obligation to share the GCP and company name with the relevant regulator and bears no liability for the consequences of any information provided by the company that is found to be inaccurate or incomplete, and
- GS1 US reserves the right to modify the use (incl. suspension and revocation of the license) of the GCP for UDI implementation in the relevant jurisdiction, as a follow-up action taken in cooperation with the relevant regulator, in case of repeated and/or deliberate misuse of the GS1 Standards related to UDI.